MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SRC14040620
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted with associated mfr# 2954740-2017-00035.Additional procode: krd.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
It was reported by a healthcare professional that the cashmere coil (src14040620/c24289) stretched during use.There were no potential adverse events.The procedure was completed with a same/like product, and there was no procedural delay.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
This is final mdr report being submitted with associated mfr# 2954740-2017-00035.Product returned.Very limited information was received.The unidentified microcatheter was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.The returned coil was stretched as reported, however the stretched coil has been completely entangled around the device positioning unit (dpu) and the introducer sheath.This entanglement of the device is all post-procedural in nature.No manufacturing defects were found.The complaint of the coil stretching is confirmed.Due to further post-procedural coil damage and without further complaint clarification, the root cause of the coil stretching cannot be determined; however, the evidence as received highly suggests that a possible contributing factor may have been due to the coil becoming temporarily anchored.When the anchored coil was retracted it is most likely when the stretching occurred, however the circumstances of how and when this damage occurred cannot be determined.In addition, without the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and the analysis, the event was confirmed, however procedural factors contributed to the event.The reported event most likely occurred due to the coil becoming temporarily anchored.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

• Brand Name: CASHMERE 14 - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6345521
• Report Number: 2954740-2017-00035
• Device Sequence Number: 425196
• Product Code: HCG
• UDI-Device Identifier: 00878528004141
• UDI-Public: (01)00878528004141(17)190114(10)C24289
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142429
• 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
• Report Date (Section B): 01/24/2017

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: 08/31/2020
• Device Catalogue Number: SRC14040620
• Device Lot Number: P11042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/21/2017
• Patient Sequence Number: 1