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

Model Number	640CF0412
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17599449 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.(b)(4).
Event or Problem Description
The healthcare professional reported that the orbit galaxy tdl complex fill coil 4x12 (640cf0412 / 17599449) was stretched during the procedure.There was no report of patient injury or complication related to the reported event.
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[complaint conclusion]: the healthcare professional reported that the orbit galaxy tdl complex fill coil 4x12 (640cf0412 / 17599449) was stretched during the procedure.There was no report of patient injury or complication related to the reported event.Investigation summary: a non-sterile orbit galaxy tdl complex fill coil 4x12 was received coiled inside a pouch.The hypotube was inspected and was found kinked at 21, 78, 143, and 144 cm from the proximal end.The coil introducer was also visually inspected and was found to be unzipped.The support coil, the gripper and the embolic coil were all outside of the introducer, were inspected and no damage was observed on these components.The microcatheter underwent microscopic inspection; the embolic coil was not stretched and no other damage was observed on the coil.The reported issue that the coil was stretched during the procedure was not confirmed.The damages observed on the received device were most likely due to excessive force.Procedural handling might have been the contributing factors to the reported issue.A review of the manufacturing documentation associated with lot 17599449 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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.

• 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: 7356068
• Report Number: 3008264254-2018-00515
• Device Sequence Number: 11094242
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: (01)10886704030270(11)161004(17)190930(10)17599449
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2018

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: 09/30/2019
• Device Model Number: 640CF0412
• Device Catalogue Number: 640CF0412
• Device Lot Number: 17599449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/07/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/15/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1