PGW .018 SV SHORT

Report

Report Number: 1016427-2010-00144
Event Type: Malfunction
Date Received: November 23, 2010
Date of Event: October 20, 2010
Report Date: November 2, 2010
Manufacturer: CORDIS CORPORATION
Product Code: DQX
PMA / PMN Number: K930091
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT CONCLUSION HAS BEEN UPDATED TO REFLECT ANALYSIS OF THE RETURNED PRODUCT. IT WAS REPORTED THAT THE END OF THE WIRE 'UNRAVELED IN THE PATIENT'S VESSEL,' BUT DID NOT SEPARATE. DURING A PTA PROCEDURE OF THE TIBIOPERONEAL TRUNK, THE WIRE PASSED THROUGH NON-CORDIS 4F COBRA C2 GUIDING CATHETER WITH EASY TRANSITION, WITHOUT EXCESSIVE TORQUE. THE 'COBRA CAME OFF' AND THE PHYSICIAN NOTICED THE END OF THE WIRE HAD UNRAVELED IN THE PATIENT'S VESSEL, BUT WAS STILL ATTACHED. THE COBRA WAS THEN RE-INTRODUCED OVER THE WIRE TO THE BEGINNING OF THE TIP, AND THE WIRE WAS PULLED THROUGH INTO THE COBRA AND BOTH WERE PULLED OUT TOGETHER. THE WIRE HAD NOT BEEN MANIPULATED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE UNIT OF PGW .018 SV SHORT 300CM ST WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE CORE WIRE WAS FRACTURED AND THE COIL WAS STRETCHED AND UNRAVELED. NO OTHER VISUAL ANOMALIES WERE NOTED ON THE RECEIVED UNIT. THE DAMAGED AREA WAS OBSERVED UNDER A MICROSCOPE AND WAS SENT TO SEM ANALYSIS TO DETERMINE THE CAUSE OF THE FRACTURE. THE SEM RESULTS SHOWED THAT THE FLAT CORE WIRE FRACTURE SURFACES PRESENTED EVIDENCE OF BENDING AND SMEARING CHARACTERISTICS. REVERSE BENDING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE BY COMPARISON WITH A SAMPLE CUT BY THE ENGINEER. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING AND THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURES AS 'DISTAL TIP- UNRAVELED/STRETCHED' WAS CONFIRMED DUE TO THE RECEIVED CONDITION OF THE DEVICE, THE CAUSE OF THIS DAMAGED COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THE EXACT CAUSE FRACTURED FOUND DURING ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED OF THE PRODUCT, SINCE THE SEM RESULTS SHOWED EVIDENCE OF BENDING AND SMEARING CHARACTERISTICS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. NEITHER THE PRODUCT NOR SEM ANALYSES SUGGEST THAT THE FAILURE COULD BE RELATED TO THE CORE WIRE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ONE NON STERILE UNIT OF PGW .018 SV SHORT 300CM ST WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE CORE WIRE WAS FRACTURED AND THE COIL WAS STRETCHED AND UNRAVELED. NO OTHER VISUAL ANOMALIES WERE NOTED ON THE RECEIVED UNIT. THE DAMAGED AREA WAS OBSERVED UNDER A MICROSCOPE AND WAS SENT TO SEM ANALYSIS TO DETERMINE THE CAUSE OF THE FRACTURE. THE SEM RESULTS SHOWED THAT THE FLAT CORE WIRE FRACTURE SURFACES PRESENTED EVIDENCE OF BENDING AND SMEARING CHARACTERISTICS. REVERSE BENDING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE BY COMPARISON WITH A SAMPLE CUT BY THE ENGINEER. (B)(6) MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING AND THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURES AS 'DISTAL TIP- UNRAVELED/STRETCHED' WAS CONFIRMED DUE TO THE RECEIVED CONDITION OF THE DEVICE, THE CAUSE OF THIS DAMAGED COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THE EXACT CAUSE FRACTURED FOUND DURING ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED OF THE PRODUCT, SINCE THE SEM RESULTS SHOWED EVIDENCE OF BENDING AND SMEARING CHARACTERISTICS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. NEITHER THE PRODUCT NOR SEM ANALYSES SUGGEST THAT THE FAILURE COULD BE RELATED TO THE CORE WIRE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

IT IS ANTICIPATED THAT THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT THE DEVICE HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THE END OF THE WIRE 'UNRAVELED IN THE PATIENT'S VESSEL,' BUT DID NOT SEPARATE. DURING A PTA PROCEDURE OF THE TIBIOPERONEAL TRUNK, THE WIRE PASSED THROUGH NON-CORDIS 4F COBRA C2 GUIDING CATHETER WITH EASY TRANSITION, WITHOUT EXCESSIVE TORQUE. THE 'COBRA CAME OFF' AND THE PHYSICIAN NOTICED THE END OF THE WIRE HAD UNRAVELED IN THE PATIENT'S VESSEL, BUT WAS STILL ATTACHED. THE COBRA WAS THEN RE-INTRODUCED OVER THE WIRE TO THE BEGINNING OF THE TIP, AND THE WIRE WAS PULLED THROUGH INTO THE COBRA AND BOTH WERE PULLED OUT TOGETHER. THE WIRE HAD NOT BEEN MANIPULATED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. LR PACKAGING L/N # 01420220, 70310738. (B)(4). WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem · 1

THE END OF THE PGW .018 SV SHORT 300CM ST WIRE "UNRAVELED IN THE PATIENT'S VESSEL," BUT DID NOT SEPARATE. DURING A PTA PROCEDURE OF THE TIBIOPERONEAL TRUNK, THE WIRE PASSED THROUGH A (B)(4) 4F COBRA C2 GUIDING CATHETER WITH EASY TRANSITION, WITHOUT EXCESSIVE TORQUE. THE "COBRA CAME OFF" AND THE PHYSICIAN NOTICED THE END OF THE WIRE HAD UNRAVELED IN THE PATIENT'S VESSEL, BUT WAS STILL ATTACHED. THE COBRA WAS THEN RE-INTRODUCED OVER THE WIRE TO THE BEGINNING OF THE TIP, AND THE WIRE WAS PULLED THROUGH INTO THE COBRA AND BOTH WERE PULLED OUT TOGETHER. THE WIRE HAD NOT BEEN MANIPULATED PRIOR TO USE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A SAVVY BALLOON AND A 0.016 HYDROPHYLIC WIRE WAS USED TO CROSS THE LESION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PGW .018 SV SHORT	ENDOVASCULAR WIRES & METALS (DQX)	DQX	CORDIS CORPORATION	NA	70310738

Patients

Seq	Age	Sex	Outcome	Treatment
1				4F COBRA C2 GUIDING CATHETER