MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0408
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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.[conclusion]: the healthcare professional reported that during the procedure, the orbit galaxy complex xtrasoft 4mm x 8cm coil (640cx0408 / 30069603), the coil introducer on the device could not be resheathed / re-zipped.There was no report of any patient consequence or adverse event associated with the event; there was no procedural delay as a result of the event.Additional information is not available.The product was returned for evaluation which revealed that the coil was kinked.The investigational finding is documented below.Investigation summary: the non-sterile orbit galaxy complex xtrasoft 4mm x 8cm coil was returned and received contained in a pouch.The hub was visually inspected and was found without damage.The hypotube was observed kinked at 30 cm, 36 cm, 41 cm, and 121 cm from the proximal end.It was also broken at 144 cm from the proximal end.There was no damage observed on the introducer tube.The support coil and the gripper were found outside of the coil introducer with no damage noted on them.The embolic coil was observed to be kinked.The returned device underwent additional microscopic inspection and the damages observed during the visual inspection were confirmed.The edges of the broken section of the hypotube showed evidence that it was kinked before it became broken.The device could not undergo functional testing due to the damages observed: kinked and broken section of the hypotube and the kinked embolic coil a review of manufacturing documentation associated with this lot (30069603) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The originally reported issue that the coil introducer could not be resheathed / re-zipped was confirmed based on the damages noted on the returned device.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 reported issue could not be conclusively determined as the device could not be functionally tested due to the condition in it was returned/received in.It is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported issue with the coil introducer not able to be resheathed / re-zipped as well as the kinked condition observed on the embolic coil of the returned device.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 procedure, the orbit galaxy complex xtrasoft 4mm x 8cm coil (640cx0408 / 30069603), the coil introducer on the device could not be resheathed / re-zipped.There was no report of any patient consequence or adverse event associated with the event; there was no procedural delay as a result of the event.Additional information is not available.The product was returned for evaluation which revealed that the coil was kinked.Based on the product analysis completed on 2/28/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8396635
• Report Number: 1226348-2019-00842
• Device Sequence Number: 19239513
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/01/2019

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: 04/30/2020
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30069603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1