MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG CMPLX XTRASOFT COIL 3.5X7.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3575
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, before a 3.5x7.5 og cmplx xtrasoft (640cx3575, 30173238) passed through the y connector, the physician found the coil stretched.The coil was changed to a new one.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Updated sections on this report: d10, g1, g4, g7, h2, h3, h6 and h10.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, before a 3.5x7.5 og cmplx xtrasoft (640cx3575, 30173238) passed through the y connector, the physician found the coil stretched.The coil was changed to a new one.There was no patient injury reported.No further information is available.One non-sterile unit og cmplx xtrasoft coil 3.5x7.5 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 inside the introducer, no other damages were observed.A manufacturing record evaluation was performed for the finished device 30173238 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - unraveled/stretched¿ was confirmed due the embolic coil was found stretched.The kinked and 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.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.Based on the limited information available for review, it is possible that procedural and handling factors may have contributed to the reported event.An embolic coil becomes stretched when an excessive pull force is applied to the device.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X7.5
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9489330
• Report Number: 1226348-2019-01033
• Device Sequence Number: 11063426
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 12/31/2020
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30173238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1