MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG CMPLX XTRASOFT COIL 3.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX3505
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the procedure, the orbit galaxy complex xtrasoft 3.5 mm x 5.0 cm coil (640cx3505 / 17685002), 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 in a stretched condition.The investigational finding is documented below.Investigation summary: the non-sterile orbit galaxy complex xtrasoft 3.5 mm x 5.0 cm coil was returned and received contained in a pouch.The device underwent visual inspection.The hub and hypotube were visually inspected; the components were observed without any damage.The introducer tube was kinked.The support coil and the gripper were outside of the introducer and were without any damage noted on them.The embolic coil was observed stretched.The returned device underwent additional microscopic inspection and the damages observed during the visual inspection were confirmed.Functional testing could not be conducted on the returned device due to its return condition.A review of manufacturing documentation associated with this lot (17685002) 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 stretched condition observed on the embolic coil of the returned device.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the orbit galaxy complex xtrasoft 3.5 mm x 5.0 cm coil left the manufacturing facility with the embolic coil in the stretched condition that was observed on 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 3.5 mm x 5.0 cm coil (640cx3505 / 17685002), 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 in a stretched condition.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 3.5X5
• 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: 8399951
• Report Number: 1226348-2019-00843
• Device Sequence Number: 11344559
• Product Code: KRD
• UDI-Device Identifier: 10886704030683
• UDI-Public: 10886704030683
• 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: 03/05/2019
• Device Catalogue Number: 640CX3505
• Device Lot Number: 17685002
• 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: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1