MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0515
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.[conclusion]: the healthcare professional reported that during the embolization procedure, the orbit galaxy complex fill 5mm x 15cm coil (640cf0515 / 17732800) could not be resheathed.It was confirmed that the coil delivery system was prepped without any issue or difficulty and adequate flush was maintained.There was no difficulty encountered during the unsheathing (stripping away) the introducer tube from the delivery tube on the detachable coil system (dcs).There was no report of patient injury or consequence related to the event.The product was returned for evaluation and the embolic coil was noted to be stretched.The investigational findings are documented below.A non-sterile orbit galaxy complex fill 5mm x 15cm coil was received coiled inside a pouch.The hypotube was inspected and was found kinked at 11 cm, 15 cm and 40 cm from the proximal end.The coil introducer was found partially unzipped and kinked.The support coil and gripper were inspected; no damages were noted on them.The embolic coil was found separated of the unit and stretched.No other damages were noted on the return device.Functional testing could not be performed due to the kinked condition of the coil introducer and on the hypotube.Based on the condition of the coil introducer in the partially zipped and kinked condition, the reported issue related to resheathing was confirmed.A review of the manufacturing documentation associated with this lot (17732800) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the limited information provided in the complaint and based on the condition of the returned device, the reported issue regarding the resheathing failure is most likely due to the kinked condition of the hypotube and on the coil introducer.Excessive force applied on the device likely contributed to the kinked observed as well as the stretched condition of the embolic coil.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.Procedural factors likely contributed to the observed stretched condition of the embolic coil.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the orbit galaxy complex fill 5mm x 15cm coil left the manufacturing facility with the embolic coil in a stretched condition.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.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 embolization procedure, the orbit galaxy complex fill 5mm x 15cm coil (640cf0515 / 17732800) could not be resheathed.It was confirmed that the coil delivery system was prepped without any issue or difficulty and adequate flush was maintained.There was no difficulty encountered during the unsheathing (stripping away) the introducer tube from the delivery tube on the detachable coil system (dcs).There was no report of patient injury or consequence related to the event.The product was returned for evaluation and the embolic coil was noted to be stretched.

• Brand Name: OG TDL CMPLX FILL COIL 5X15
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 7952666
• Report Number: 1226348-2018-00751
• Device Sequence Number: 1386820
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: 10886704030300
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 07/31/2019
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17732800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1