MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0412
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is: krd/hcg.(b)(6).The initial reporter email address is not available.Conclusion: the healthcare professional reported that during the coil embolization procedure targeting an unruptured aneurysm, the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30029281) was used but the coil could not be detached even though several attempts were made to detach the coil.The coil was successfully removed from the patient.It was reported that the coil delivery system was prepped without any difficulty.The coil was replaced with a competitive product and the procedure was completed.The reported event did not result in any interruption of blood flow.There was no report of patient injury / complication or procedural delay as a result of the reported event.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30029281) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.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.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, 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 is one of 2 products involved with the reported complaint.The associated manufacturer report number is 3008114965-2019-01145.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure targeting an unruptured aneurysm, the 4mm x 12cm orbit galaxy complex fill coil (640cf0412 / 30029281) was used but the coil could not be detached even though several attempts were made to detach the coil.The coil was successfully removed from the patient.It was reported that the coil delivery system was prepped without any difficulty.The coil was replaced with a competitive product and the procedure was completed.The reported event did not result in any interruption of blood flow.There was no report of patient injury / complication or procedural delay as a result of the reported event.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8899535
• Report Number: 1226348-2019-00976
• Device Sequence Number: 19236748
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 640CF0412
• Device Lot Number: 30029281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1