PGW .018 SV SHORT 300CM ST

Report

Report Number: 9616099-2021-04770
Event Type: Malfunction
Date Received: August 10, 2021
Date of Event: July 16, 2021
Report Date: January 7, 2022
Manufacturer: CORDIS CORPORATION
Product Code: DQX
PMA / PMN Number: K930091
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2021-04769 AND 1016427-2021-05375. THREE NON-STERILE GUIDEWIRES ¿PGW .018 SV SHORT 180CM ST¿ WERE RECEIVED COILED INSIDE OF A CLEAR PLASTIC BAG. THE GUIDEWIRES WERE UNPACKED AND LAID IT ON A TRAY TO BE VISUALLY INSPECTED. THE UNIT RETURNED UNDER THIS EVENT WAS THOROUGHLY INSPECTED OBSERVING THAT THE COIL WIRE PRESENTED AN UNRAVELED\STRETCHED CONDITION LOCATED AT THE DISTAL CORE WIRE (RIBBON). NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED UNIT. THE DISTAL TIP SECTION WAS ANALYZED USING A VISION SYSTEM TO MAGNIFY THE DAMAGED AREA. THE CONDITION OF UNRAVELED WAS CONFIRMED, THE DISTAL TIP OF THE COIL WIRE THAT SHOULD BE FUSED WITH THE CORE WIRE WAS NOTICED SEPARATED CAUSING THIS CONDITION. SEM RESULTS SHOWED THE SEPARATED AREA OF THE PGW .018 SV SHORT 300 CM ST GUIDEWIRE UNIT PRESENTED EVIDENCE OF PLASTIC DEFORMATION, DUCTILE DIMPLES AND CUP AND CONE-LIKE SHAPE ON THE WIRE OF THE UNIT. THE PLASTIC DEFORMATION, DUCTILE DIMPLES AND CUP AND CONE-LIKE SHAPE ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE WIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. NO OTHER ANOMALIES WERE OBSERVED DURING SEM ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 0

A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 0

UPDATED H6 EVALUATION CODES: 1454- PEELED; GUIDEWIRE-463. THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2021-04769 AND 1016427-2021-05375. COMPLAINT CONCLUSION: AS REPORTED, THE TWO .018 X 300CM STRAIGHT TIP SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) WERE FRAYED INSIDE THE PATIENT. THERE WAS DIFFICULTY TRACKING THE WIRES THROUGH THE VESSEL OR LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. AN ADDITIONAL NON-STERILE DEVICE WAS RETURNED FOR EVALUATION RELATED TO THE EVENT. ON THE SECOND AND THIRD DEVICES RECEIVED THE DISTAL PORTION OF THE COIL WIRE SEPARATED FROM THE CORE WIRE HOWEVER, THE PROXIMAL END OF THE COIL WIRE REMAINS ATTACHED TO THE CORE WIRE. THE UNRAVELING OF THE COIL WIRE RESULTED IN THE EXPOSURE OF THE GUIDEWIRE CORE WIRE. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE INTENDED PROCEDURE WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT KINK NOR BEND AT ANY TIME. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THE PRODUCT WAS RESTERILIZED WHEN REMOVED FROM THE PATIENT. THE EVENT OCCURRED WHILE CROSSING THE LESION. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES. THE WIRE DID NOT KINK WHILE BEING USED. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME. THE WIRE WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN .018 WIRE. THREE NON-STERILE 300CM STRAIGHT TIP SV .018¿ PERIPHERAL STEERABLE GUIDEWIRES WERE RECEIVED FOR ANALYSIS. VISUAL ANALYSIS ON THE SECOND DEVICE REVEALED THE RADIOPAQUE DISTAL COIL WIRE WAS UNRAVELED. THE DISTAL TIP WAS ANALYZED USING A VISION SYSTEM TO MAGNIFY THE DAMAGED AREA. THE DISTAL TIP OF THE COIL WIRE SEPARATED FROM THE CORE WIRE HOWEVER, THE PROXIMAL END OF THE COIL WIRE REMAINS ATTACHED TO THE CORE WIRE. THE UNRAVELING OF THE COIL WIRE RESULTED IN THE EXPOSURE OF THE GUIDEWIRE CORE WIRE. SEM ANALYSIS OF THE SEPARATED AREA PRESENTED EVIDENCE OF PLASTIC DEFORMATION, A CUP AND CONE-LIKE SHAPE AND DUCTILE DIMPLES. THE PROXIMAL END OF THE COIL WIRE REMAINS ATTACHED TO THE CORE WIRE. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35261025 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINT, ¿DISTAL TIP-WIRES - FRAYED/SPLIT/TORN - IN PATIENT¿ WAS NOT CONFIRMED. NONE OF THE RETURNED DEVICES PRESENTED WITH THIS CONDITION. THE COMPLAINT ¿GUIDEWIRE ~ TRACKING DIFFICULTY¿ WAS NOT CONFIRMED BECAUSE THIS MALFUNCTION CANNOT BE PROPERLY REPRODUCED IN A LABORATORY SETTING. THE MALFUNCTIONS ¿DISTAL TIP-WIRES - FRACTURED¿ AND ¿GUIDEWIRE-EXPOSED BRAIDWIRE/COREWIRE¿ WERE CONFIRMED ON THE SECOND AND THIRD WIRE. THE DISTAL TIP OF THE COIL WIRE SEPARATED FROM THE CORE WIRE ON THESE DEVICES WITH THE PROXIMAL END OF THE COIL WIRE REMAINING ATTACHED TO THE CORE WIRE. THE FIRST ANALYZED DEVICE DID NOT PRESENT WITH THESE CONDITIONS. THE CAUSE OF THIS DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. PLASTIC DEFORMATION, DUCTILE DIMPLES AND CUP AND CONE-LIKE SHAPE ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE WIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE, DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL. GUIDEWIRE MANIPULATION/TORQUING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. SHOULD THE GUIDEWIRE TIP BECOME ENTRAPPED WITHIN THE VASCULATURE (I.E., SMALL SIDE BRANCH, TIGHT STENOSIS), DO NOT TORQUE THE GUIDEWIRE. ADVANCE THE BALLOON CATHETER DISTALLY, GENTLY PULL THE GUIDEWIRE BACK INTO THE BALLOON CATHETER, AND REMOVE THE BALLOON CATHETER/GUIDEWIRE SYSTEM AS A UNIT. SHOULD TORQUE CONTROL/TIP RESPONSE BE COMPROMISED DURING USE, CONFIRM TIP INTEGRITY USING FLUOROSCOPY. LOSS OF TORQUE CONTROL MAY BE DUE TO CORE WIRE FRACTURE. UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE BALLOON CATHETER TO THE DISTAL END OF THE GUIDEWIRE AND REMOVE THE BALLOON CATHETER/GUIDEWIRE SYSTEM AS A UNIT. DO NOT PULL THE DISTAL TIP TO REMOVE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP. GENTLY INTRODUCE AND ADVANCE THE GUIDEWIRE TO PREVENT DAMAGING THE DISTAL TIP.¿ BASED ON THE INFORMATION AVAILABLE, PRODUCT ANALYSIS, AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 0

THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem · 0

AS REPORTED, THE TWO (2) .018 X 300CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WERE FRAYED INSIDE THE PATIENT. THERE WAS DIFFICULTY TRACKING THE WIRES THROUGH THE VESSEL OR LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. AN ADDITIONAL NON-STERILE DEVICE WAS RETURNED FOR EVALUATION RELATED TO THE EVENT. THE DISTAL TIP OF THE COIL WIRE THAT SHOULD BE FUSED WITH THE CORE WIRE WAS NOTICED SEPARATED ON THE SECOND AND THIRD DEVICES RECEIVED. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE INTENDED PROCEDURE WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT KINK NOR BEND AT ANY TIME. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THE PRODUCT WAS RESTERILIZED WHEN REMOVED FROM THE PATIENT. THE EVENT OCCURRED WHILE CROSSING THE LESION. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES. THE WIRE DID NOT KINK WHILE BEING USED. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME. THE WIRE WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN .018 WIRE. THE DEVICES WILL BE RETURNED FOR ANALYSIS INCLUDING THE TWENTY-SIX (26) UNUSED DEVICES FROM THE SAME BOX.

Additional Manufacturer Narrative · 1

THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2021-04769. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem · 1

AS REPORTED, THE TWO (2) .018 X 300CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WERE FRAYED INSIDE THE PATIENT. THERE WAS DIFFICULTY TRACKING THE WIRES THROUGH THE VESSEL OR LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE INTENDED PROCEDURE WAS A PERIPHERAL ANGIOGRAM. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE DID NOT KINK NOR BEND AT ANY TIME. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THE PRODUCT WAS RESTERILIZED WHEN REMOVED FROM THE PATIENT. THE EVENT OCCURRED WHILE CROSSING THE LESION. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES. THE WIRE DID NOT KINK WHILE BEING USED. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME. THE WIRE WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN .018 WIRE. THE DEVICES WILL BE RETURNED FOR ANALYSIS INCLUDING THE TWENTY-NINE (29) UNUSED DEVICES FROM THE SAME BOX.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1199324	PGW .018 SV SHORT 300CM ST	WIRE, GUIDE, CATHETER	DQX	CORDIS CORPORATION	503558X	35261681

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		UNK.