MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL YOGA 24, 0.024" ID, 150CM; CATHETER, PERCUTANEOUS

Catalog Number	MC24150Z
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Physical manufacturer: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The name of the initial reporter is unknown.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
As reported by an affiliate, during a coil embolization of an aneurysm for thrombus recovery at the middle cerebral artery (m1), a revive se thrombectomy device (frs21452299, s12435) was inserted into the yoga microcatheter (mc24150z, c42381) but there was strong resistance felt in the catheter.Therefore, the stent was replaced with another one (solitaire).However, it could not be reached to the lesion although it was more advanced than the revive.Therefore, the micro catheter was replaced with a non-cerenovus microcatheter.The procedure was successfully completed without further issues or delay.There was no patient injury or complications reported.The products are not available for the investigation.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.It was a case that there was heavily tortuousness due to bovine and difficult to approach.No report of the other device used in the procedure is available.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).Additional information indicated that there was no loss of mc cerebral target position when resistance was with the revive.Complaint conclusion: as reported by an affiliate, during a coil embolization of an aneurysm for thrombus recovery at the middle cerebral artery (m1), revive se thrombectomy device ((b)(4), s12435) was inserted into the yoga microcatheter (mc24150z, c42381) but there was strong resistance felt in the catheter.Therefore, the stent was replaced with another one (solitaire).However, it could not be reached to the lesion although it was more advanced than revive.Therefore, the micro catheter was replaced with a non-cerenovus microcatheter.The procedure was successfully completed without further issues or delay.There was no patient injury or complications reported.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.It was a case that there was heavily tortuousness due to bovine and difficult to approach.The patient¿s vessel level of tortuousness and calcification were unknown.No report of the other device used in the procedure is available.Additional information indicated that there was no loss of mc cerebral target position when resistance was with the revive.No further information is available.(b)(4).The yoga 24 product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Based on the information provided and without the products available for analysis, it is not possible to draw a conclusion about a clinical relationship between the device and the event of obstructed with microcatheter.However, there are possible vessel characteristics, specifically the tortuosity of the vessel that may have contributed to the event.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: YOGA 24, 0.024" ID, 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7307569
• Report Number: 3008114965-2018-00540
• Device Sequence Number: 19168047
• Product Code: DQY
• UDI-Device Identifier: 10886704079255
• UDI-Public: 10886704079255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 09/30/2020
• Device Catalogue Number: MC24150Z
• Device Lot Number: C42381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1