MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG CMPLX XTRASOFT COIL 3X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0308
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
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.The company is seeking this information through the event investigation.Procode: krd/hcg.The company is seeking this information through the event investigation.The product is available for evaluation and testing; however, it has not been received to date.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, when the physician tried detaching the first coil, a 3x8 og cmplx xtrasoft coil (640cx0308, 30254263), the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery system.The physician used a same like product.The procedure was successfully finished.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Updated sections on this report: d10, 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, when the physician tried detaching the first coil, a 3x8 og cmplx xtrasoft (640cx0308, 30254263), the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery system.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.One non-sterile unit og cmplx xtrasoft coil 3x8 was received inside of a pouch.The received device was visually inspected, the hypo-tube was found several kinked.Then a microscopic inspection was performed, the embolic coil was not returned for analysis, no other damages were observed.A manufacturing record evaluation was performed for the finished device 30254263 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be confirmed due the embolic coil was already detached from the device.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.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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 3X8
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9728419
• Report Number: 1226348-2020-00010
• Device Sequence Number: 1964557
• Product Code: KRD
• UDI-Device Identifier: 10886704030607
• UDI-Public: 10886704030607
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 05/31/2021
• Device Model Number: 640CX0308
• Device Catalogue Number: 640CX0308
• Device Lot Number: 30254263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1