MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPL CERE COIL SYS 3X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10030430
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
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.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure, before the coil was introduced into the patient, while unsheathing the 3 mm x 4 cm deltaplush 10 cerecyte coil (cpl10030430 / c32159) to introduce into the sl-10® microcatheter (stryker), part of the sheath came off.The coil was removed from the microcatheter without any damage noted on it.The coil delivery system was reported to have been prepped without any difficulty.It was confirmed that excessive force was not applied and adequate was reported to have been maintained.There was no damage observed on the microcatheter; the same microcatheter was used to complete the procedure.There was no report of any patient injury or complication; no procedural delay associated with the reported issue.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: a non-sterile 3 mm x 4 cm deltaplush 10 cerecyte coil was received contained in a pouch.The returned device underwent visual inspection.The hub was without any damage.The device positioning unit (dpu) was in good condition.The introducer was zipped and also without any appearance of damage noted.The resheathing tool was broken in two pieces.The embolic coil and resheathing tool were both outside of the introducer.Microscopic inspection was performed.The v-notch was observed in normal good condition.The resistance heating (rh) was inspected and found to be in good condition; the rh was not heated.The embolic coil was noted to be in stretched.Functional testing could not be performed due to the broken resheathing tool.A review of manufacturing documentation associated with this lot (c32159) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the coil introducer separated during use could not be confirmed through the functional analysis on the returned device as the device could not undergo functional testing due to the broken condition of the resheathing tool.The issue related to the difficulty in unsheathing was confirmed; likely due to the broken resheathing tool.The exact cause of the broken resheathing tool could not be determined as based on the device history record review, there is no indication that the event is related to the device manufacturing process.Coil stretching is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during attempts to withdrawal the coil against resistance.It is also possible that the coil may have become stretched when it was being removed from the microcatheter, but the issue was not noted at the time.The exact cause of the stretched condition of the coil was not conclusively determined with the visual and microscopic inspection of the returned device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 3 mm x 4 cm deltaplush 10 cerecyte 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 of failure to detach 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 coil embolization procedure, before the coil was introduced into the patient, while unsheathing the 3 mm x 4 cm deltaplush 10 cerecyte coil (cpl10030430 / c32159)to introduce into the sl-10® microcatheter (stryker), part of the sheath came off.The coil was removed from the microcatheter without any damage noted on it.The coil delivery system was reported to have been prepped without any difficulty.It was confirmed that excessive force was not applied and adequate was reported to have been maintained.There was no damage observed on the microcatheter; the same microcatheter was used to complete the procedure.There was no report of any patient injury or complication; no procedural delay associated with the reported issue.The product was returned for evaluation which revealed that the coil was in a stretched condition.Based on the product analysis completed on 4/15/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPL CERE COIL SYS 3X4
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8516568
• Report Number: 3008114965-2019-00988
• Device Sequence Number: 13941976
• Product Code: HCG
• UDI-Device Identifier: 00878528008279
• UDI-Public: 00878528008279
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: CPL10030430
• Device Lot Number: C32159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1