MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASH 14 CERE 3MMX6.0CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CRC14030630
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (s13696) 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2019-00893, and 1226348-2019-00832.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 interventional embolization of a posterior communication artery aneurysm, the first two coils: a 5 mm x 17 cm presidio 10 cerecyte (pc410051730 / s12276) and a 2 mm x 6 cm deltapaq 10 cerecyte (cdf10020630 / s37678) advanced smoothly without any issue through the 150 cm prowler14 microcatheter (606151x / lot# unknown).The third coil chosen was the 3 mm x 6 cm cashmere 14 cerecyte coil (crc14030630 / s13696).When the physician attempted to advance this coil to the target site for implantation, he found it hard to push the coil in the microcatheter.It was also hard to pull the coil back out from the microcatheter.The physician could only pull the cashmere 14 cerecyte coil out with the prowler 14 microcatheter.The event resulted in the loss of the target site as both the coil and the microcatheter were replaced.The procedure was completed using another coil and microcatheter.The procedure was successfully completed without any delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.It was reported that the product is available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on (b)(6) 2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2019-00893, and 1226348-2019-00832.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the interventional embolization of a posterior communication artery aneurysm, the first two coils: a 5 mm x 17 cm presidio 10 cerecyte ((b)(4).) and a 2 mm x 6 cm deltapaq 10 cerecyte (cdf10020630 / s37678) advanced smoothly without any issue through the 150 cm prowler14 microcatheter (606151x / lot# unknown).The third coil chosen was the 3 mm x 6 cm cashmere 14 cerecyte coil ((b)(4).).When the physician attempted to advance this coil to the target site for implantation, he found it hard to push the coil in the microcatheter.It was also hard to pull the coil back out from the microcatheter.The physician could only pull the cashmere 14 cerecyte coil out with the prowler 14 microcatheter.The event resulted in the loss of the target site as both the coil and the microcatheter were replaced.The procedure was completed using another coil and microcatheter.The procedure was successfully completed without any delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: a non-sterile 3 mm x 6 cm cashmere 14 cerecyte coil was received contained in a pouch with the prowler 14 microcatheter.An unknown y-connector was attached to the hub of the microcatheter.The device positioning unit (dpu) and the introducer of the cashmere coil were kinked.The introducer was unzipped.The embolic coil was inside the prowler microcatheter.The cashmere coil underwent microscopic inspection and the embolic coil was observed stretched and kinked.The resistance heating (rh) had no evidence of being heated.The microcatheter was observed to be compressed; no other damage was noted.Functional test was performed using the y connector received with the microcatheter.The device was flushed, and the cashmere coil passed through the prowler microcatheter without issue until it reached the compressed section where there was resistance/friction felt.The coil was able to advance through the compressed section even with the experienced resistance/friction.A review of manufacturing documentation associated with this lot (s13696) 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 reported issue that the 3 mm x 6 cm cashmere 14 cerecyte coil could not be advanced to the target site, that the coil became impeded in the microcatheter was not confirmed with the functional analysis that was performed on the returned device.While there was resistance/friction during the advancement of the coil through the observed compressed area of the microcatheter, the coil was able to pass through this section.Coil kinked and stretched are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink and stretching from occurring.The coil kinked and stretched conditions were not originally reported with the complaint.The exact cause of the observed kinked and stretched condition of the embolic coil could not be conclusively determined; however, the complaint documented that the physician found it hard to push the coil in the microcatheter and hard to pull the coil back out from the microcatheter.As a result, both the cashmere coil and the prowler microcatheter were removed.The coil could have become kinked and stretched when the physician was attempting to advance and ultimately remove it.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 6 cm cashmere 14 cerecyte coil left the manufacturing facility with the embolic coil in the kinked and stretched conditions that were 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 1226348-2019-00832.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: CASH 14 CERE 3MMX6.0CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CA CH-24 00; SZ CH-2400
• MDR Report Key: 8308403
• Report Number: 3008114965-2019-00893
• Device Sequence Number: 62079
• Product Code: HCG
• UDI-Device Identifier: 00878528004448
• UDI-Public: 00878528004448
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2019

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: 03/31/2022
• Device Catalogue Number: CRC14030630
• Device Lot Number: S13696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 04/16/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/12/2019; 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 150 CM DUAL MARKER PROWLER14 MICROCATHETER