MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG CMPLX XTRASOFT COIL 4X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0406
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.One non-sterile unit og cmplx xtrasoft coil 4x6 was received inside of a pouch.The received device was visually inspected; no damages were noticed.Then a microscopic inspection was performed, the embolic coil was found stretched still inside of the introducer, no other damages were observed.A manufacturing record evaluation was performed for the finished device 30165279 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 4x6 og cmplx xtrasoft coil (640cx0406, 30165279) could not advance in the y connector.The physician withdrew the unit together from the patient.There was patient injury reported.The device was not able to move at all due to the resistance.The user was not able to torque the device.There was no evidence of physical material within the device.The resistance was felt in the body of the product.No other devices were used successfully with the concomitant device after the encountered resistance.The og cmplx xtrasoft coil nor the concomitant device kinked or bent prior to the resistance or noted after removal from the patient.Based on the product analysis, the embolic coil was found stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that when the device was removed from the patient, there was no damage on any part of the device.The 4x6 og cmplx xtrasoft coil was the first coil used with the mc.The treatment was to a cerebral vessel.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization, a 4x6 og cmplx xtrasoft coil (640cx0406, 30165279) could not advance in the y connector.The physician withdrew the unit together from the patient.There was patient injury reported.The device was not able to move at all due to the resistance.The user was not able to torque the device.There was no evidence of physical material within the device.The resistance was felt in the body of the product.No other devices were used successfully with the concomitant device after the encountered resistance.The og cmplx xtrasoft coil nor the concomitant device kinked or bent prior to the resistance or noted after removal from the patient.Based on the product analysis, the embolic coil was found stretched.Additional information received indicated that when the device was removed from the patient, there was no damage on any part of the device.The 4x6 og cmplx xtrasoft coil was the first coil used with the mc.The treatment was to a cerebral vessel.One non-sterile unit og cmplx xtrasoft coil 4x6 was received inside of a pouch.The received device was visually inspected, no damages were noticed.Then a microscopic inspection was performed, the embolic coil was found stretched still inside of the introducer, no other damages were observed.A manufacturing record evaluation was performed for the finished device 30165279 number, and no non-conformances related to the reported complaint condition were identified.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.The complaint reported by the customer ¿detachable coil delivery system (dcs)- impeded with loss of cerebral target position¿ was confirmed.The embolic coil was found stretched still inside of the introducer and it was unable to move.However, the damaged condition noted on the embolic coil may have contributed to an impediment and due to this we can confirm the complaint.The stretched condition appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.Stretching is generally caused by the application of excessive force to a device while trying to retract against resistance.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG CMPLX XTRASOFT COIL 4X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9779753
• Report Number: 1226348-2020-00015
• Device Sequence Number: 2650410
• Product Code: KRD
• UDI-Device Identifier: 10886704030621
• UDI-Public: 10886704030621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 640CX0406
• Device Catalogue Number: 640CX0406
• Device Lot Number: 30165279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1