MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

Device Problem Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).(b)(6).A review of manufacturing documentation associated with this lot (l15893) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 Description

The healthcare professional reported that during the embolectomy procedure with the target at the left middle cerebral artery (mca), the 4.5 mm revive se thrombectomy device (frs21452299 / l15893) could not cross through the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown).It was reported that the insertion tool was securely placed in the hub of the microcatheter prior the attempt to advance the device.The device was flushed without difficulty and continuous flush was maintained through the microcatheter; there was resistance at the distal end of the microcatheter.The device did not deploy in the microcatheter hub and could be advanced through the hub.The device was not able to move within the microcatheter.It was not known if there was any damage to the microcatheter.The physician replaced the microcatheter, but the issue was not resolved.The physician replaced the revive se device with the 6mm x 30mm solitaire¿ fr revascularization device (medtronic) and completed the procedure using the same original prowler select plus microcatheter; additional information confirmed that there was no issue with the prowler select plus microcatheter.The reported issue did not result in any blood flow restriction / reduction.No clinically significant delay in the procedure was reported.There was no report of any patient adverse event or complication.

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 embolectomy procedure with the target at the left middle cerebral artery (mca), the 4.5 mm revive se thrombectomy device (frs21452299 / l15893) could not cross through the 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown).It was reported that the insertion tool was securely placed in the hub of the microcatheter prior the attempt to advance the device.The device was flushed without difficulty and continuous flush was maintained through the microcatheter; there was resistance at the distal end of the microcatheter.The device did not deploy in the microcatheter hub and could be advanced through the hub.The device was not able to move within the microcatheter.It was not known if there was any damage to the microcatheter.The physician replaced the microcatheter, but the issue was not resolved.The physician replaced the revive se device with the 6mm x 30mm solitaire¿ fr revascularization device (medtronic) and completed the procedure using the same original prowler select plus microcatheter; additional information confirmed that there was no issue with the prowler select plus microcatheter.The reported issue did not result in any blood flow restriction / reduction.No clinically significant delay in the procedure was reported.There was no report of any patient adverse event or complication.The complaint device was received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5 mm revive se thrombectomy device was received contained in a pouch.Visual inspection was performed.It was noted that the device was returned without the introducer.No other damage / anomaly was observed.Functional evaluation could not be performed without the introducer being returned.Without the introducer returned, the ¿basket¿ component of the revive se device is in the expanded state.A review of manufacturing documentation associated with this lot (l15893) 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 complaint documented that during the embolectomy procedure, the 4.5 mm revive se thrombectomy device could not cross through the 150cm x 5cm prowler select plus microcatheter.It could not be advanced through the hub of the microcatheter and was impeded in the microcatheter.The reported issue could not be confirmed through functional evaluation as the device was returned without the introducer, which precluded it from undergoing functional testing.The issue was confirmed based on the state of the stent component of the returned device.The revive se stent was in the expanded state because it was returned without the introducer.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 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.

• Brand Name: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10804511
• MDR Text Key: 228255718
• Report Number: 3008114965-2020-00480
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00878528000006
• UDI-Public: 878528000006
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: FRS21452299
• Device Lot Number: L15893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM.; SOLITAIRE¿ FR REVASCULARIZATION DEVICE (MEDTRONIC).
• Patient Age: 68 YR
• Patient Weight: 70