MICRUSFRAME14 8MM X 20CM

Report

Report Number: 3008114965-2019-00934
Event Type: Malfunction
Date Received: March 1, 2019
Date of Event: November 7, 2018
Report Date: November 7, 2018
Manufacturer: SEE H.10
Product Code: KRD
UDI-DI: 10886704078029
PMA / PMN Number: K150319
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. (B)(4). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (FREMONT). REPORT SOURCE: (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A SPLANCHNIC ARTERY ANEURYSM AT THE RENAL ARTERY. THE TARGET LESION WAS REPORTED TO HAVE A WIDE NECK AND AS A RESULT, BECAME A BALLOON-ASSISTED COIL EMBOLIZATION PROCEDURE. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) WAS DELIVERED TO THE LESION AND THE COIL EMBOLIZATION PROCEDURE WAS INITIATED. THE 8MM X 20CM MICRUSFRAME 14 COIL (MFR140820 / S13812) WAS ONE OF THE COILS USED AND IT WAS INSERTED INTO THE MICROCATHETER, BUT THERE WAS SOME RESISTANCE FELT IN THE SHEATH INTRODUCER AND THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. IT WAS CONFIRMED THAT CONTINUOUS AND ADEQUATE FLUSH WAS MAINTAINED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONTINUOUS FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. IT WAS REPORTED THAT THIS PROCEDURE WAS THE HOSPITAL¿S FIRST TIME USE OF THE SPECTRA COILS. THE 8MM X 20CM MICRUSFRAME 14 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS KINKED AND STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿ INVESTIGATION SUMMARY: THE 8MM X 20CM MICRUSFRAME 14 COIL WAS RETURNED WITH THE COIL PROTRUDING FROM THE INTRODUCER SKIVE. THE FLEXIBLE, DISTAL SECTION OF THE DEVICE POSITIONING UNIT (DPU) CORE WIRE, ARTICULATING JOINT, AND PROXIMAL SECTION OF THE EMBOLIC COIL WERE SEEN OUTSIDE THE INTRODUCER. BLOOD WAS SEEN INSIDE ALONG THE INTRODUCER LENGTH. KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AT APPROXIMATELY 73 CM AND 105 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. A SIGNIFICANT AMOUNT OF BLOOD WAS SEEN IN THE INTRODUCER, ESPECIALLY DISTAL TO THE EMBOLIC COIL NEAR THE INTRODUCER TRANSITION TO ITS DISTAL GREEN SECTION. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. BLOOD WAS SEEN COVERING THE EMBOLIC COIL INSIDE THE INTRODUCER SHEATH. THE EMBOLIC COIL WAS SEEN PROTRUDING FROM THE SKIVE OF THE INTRODUCER. THE SKIVE HAD BEEN WIDENED AT THIS POINT. THE EMBOLIC COIL WAS KINKED AT THE AREA OF PROTRUSION AND WAS STRETCHED PROXIMAL TO THE AREA OF PROTRUSION. THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED, INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE ARTICULATING JOINT WAS SEEN INTACT. THE FLEXIBLE AREA OF THE DPU CORE WIRE PROXIMAL TO THE DISTAL MARKER BAND HAD BEEN KINKED. BLOOD WAS SEEN COVERING THE DISTAL END OF THE DPU CORE WIRE. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S13812) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE ISSUE REPORTED IN THE COMPLAINT THAT THE 8MM X 20CM MICRUSFRAME 14 COIL ENCOUNTERED SOME RESISTANCE IN THE SHEATH INTRODUCER COULD NOT BE CONFIRMED AS THE DEVICE COULD NOT BE ADVANCED THROUGH A LAB MICROCATHETER DUE TO THE CONDITION IN WHICH IT WAS RETURNED. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) USED IN THE PROCEDURE WAS NOT RETURNED FOR FAILURE ANALYSIS. THE PRESENCE OF BLOOD SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE INSTRUCTION FOR USE (IFU) STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE; IT ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. IT IS POSSIBLE THAT THE COIL PROTRUDED FROM THE INTRODUCER SKIVE AND WAS STRETCHED DUE TO EXCESSIVE FORCE IN RESPONSE TO THE RESISTANCE CAUSED BY BLOOD. THE KINKED AREA OF THE COIL WAS AT THE PROTRUSION AND THE STRETCHED CONDITION OF THE COIL WAS AT THE PROXIMAL AREA OF THE PROTRUSION MIGHT HAVE ALSO BEEN RESULTS OF FORCE APPLIED IN RESPONSE TO THE RESISTANCE THAT WAS CAUSED BY THE BLOOD. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COILS. THUS, IT IS NOT LIKELY THAT THE 8MM X 20CM MICRUSFRAME 14 COIL LEFT THE MANUFACTURING FACILITY WITH THE COIL IN KINKED AND STRETCHED CONDITION. IN THE REVIEW OF THE DEVICE HISTORY RECORD, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS PRODUCT ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2018-00799 AND 3008114965-2019-00934. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

Description of Event or Problem · 1

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A SPLANCHNIC ARTERY ANEURYSM AT THE RENAL ARTERY. THE TARGET LESION WAS REPORTED TO HAVE A WIDE NECK AND AS A RESULT, BECAME A BALLOON-ASSISTED COIL EMBOLIZATION PROCEDURE. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) WAS DELIVERED TO THE LESION AND THE COIL EMBOLIZATION PROCEDURE WAS INITIATED. THE 8MM X 20CM MICRUSFRAME 14 COIL (MFR140820 / S13812) WAS ONE OF THE COILS USED AND IT WAS INSERTED INTO THE MICROCATHETER, BUT THERE WAS SOME RESISTANCE FELT IN THE SHEATH INTRODUCER AND THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. IT WAS CONFIRMED THAT CONTINUOUS AND ADEQUATE FLUSH WAS MAINTAINED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONTINUOUS FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. IT WAS REPORTED THAT THIS PROCEDURE WAS THE HOSPITAL¿S FIRST TIME USE OF THE SPECTRA COILS. THE 8MM X 20CM MICRUSFRAME 14 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS KINKED AND STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
174707	MICRUSFRAME14 8MM X 20CM	NEUROVASCULAR EMBOLIZATION DEVICE	KRD	SEE H.10		S13812	10886704078029

Patients

Seq	Age	Sex	Outcome	Treatment
1