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

Catalog Number	638CF0515
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned.If the device returns, a device investigation will be performed.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 of an intracranial aneurysm, the trufill dcs orbit complex fill 5mm x 15cm coil (638cf0515 / 17710998) became stretched during insertion through the microcatheter (unknown brand).Resistance at any time during the advancement of the coil through the microcatheter was not reported.It was confirmed that there was no kink on the microcatheter that could have contributed to the reported issue.There was continuous flush maintained through the microcatheter.Any resistance between the guidewire and microcatheter during the access of the target site was not reported.The entire trufill dcs orbit complex fill coil was withdrawn and removed undetached and without any additional damage; it was replaced with another coil to complete the procedure.There was no flow reduction or restriction associated with the reported issue.There was no report of patient injury or adverse event associated with the issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an intracranial aneurysm, the trufill dcs orbit complex fill 5mm x 15cm coil (638cf0515 / 17710998) became stretched during insertion through the microcatheter (unknown brand).Resistance at any time during the advancement of the coil through the microcatheter was not reported.It was confirmed that there was no kink on the microcatheter that could have contributed to the reported issue.There was continuous flush maintained through the microcatheter.Any resistance between the guidewire and microcatheter during the access of the target site was not reported.The entire trufill dcs orbit complex fill coil was withdrawn and removed undetached and without any additional damage; it was replaced with another coil to complete the procedure.There was no flow reduction or restriction associated with the reported issue.There was no report of patient injury or adverse event associated with the issue.The trufill dcs orbit complex fill 5mm x 15cm coil was returned for evaluation.The investigational finding is documented below.A non-sterile trufill dcs orbit complex fill 5mm x 15cm coil was received contained in a pouch.The hypotube was inspected and no damage was noted on it.The coil introducer was found zipped, residues of dry blood can be observed inside the introducer.Part of the support coil was found kinked and outside of the coil introducer at the proximal end.The gripper and embolic coil were inspected under the microscope.Both were inside the introducer.The gripper did not have any damage on it.The embolic coil was inside the introducer and through the microscope, was observed to be stretched.The microscopic visual inspection confirmed the stretched condition of the coil.A review of the of the manufacturing documentation associated with lot 17710998 documented that two (2) units were rejected due to the defect stretched / kinked coil.The device history record (dhr) review confirmed that all rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.Coil assembly subassembly lot 17682248 was also reviewed.There were no issues presented during the manufacturing or inspection process that can be related to the complaint.The reported issue that the trufill dcs orbit complex fill 5mm x 15cm coil became stretched during insertion through the microcatheter was confirmed with the microscopic visual inspection of the returned device.The likely cause of the stretched embolic coil was due to applied excessive force, however, this cannot be conclusively determined.Procedural factors and handling process may have contributed to the reported stretched condition of the coil.With the information provided in the complaint and the device returned, it was confirmed that the reported issue of the trufill dcs orbit complex fill 5mm x 15cm coil was stretched.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 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 trufill dcs orbit complex fill 5mm x 15cm coil left the manufacturing facility with the embolic coil in a stretched condition.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.

• Brand Name: ORBIT COMPLEX FILL 5X15 TDL
• 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: 7922849
• Report Number: 1226348-2018-00732
• Device Sequence Number: 1787208
• Product Code: HCG
• UDI-Device Identifier: 10886704029991
• UDI-Public: 10886704029991
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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: 06/30/2019
• Device Catalogue Number: 638CF0515
• Device Lot Number: 17710998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1