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

Catalog Number FRS21452299

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.An angiographic image was turned for analysis and an independent physician review was performed.The results are as follows: the case report above is accompanied by two images of the product packaging.There is no information about the catheter used when they attempted to deliver the revive se or how they prepared the device, such as whether the catheter was on a flush or not.There is no information about the device itself when it was removed, such as if it was damaged or not.Stent retrievers in general can require a modicum of force to deliver and if the doctor is not careful to deliver the forces required along the axis of the pusher wire, the wire can bend or break.However, given the paucity of information, it is challenging to conclude anything concrete from this case.Further investigation will be performed once the device returns for analysis.A manufacturing record evaluation was performed for the finished device l15943 number, and no non-conformances related to the reported complaint condition were identified.

Event Description

As reported by the field, during a percutaneous intracavitary thrombectomy of cerebrovascular vessels, the external part of the delivery wire of a 4.5mm revive se thrombectomy device (frs21452299, l15943) was ¿broken¿.The delivery wire was broken outside of the patient¿s body when its far-end was implanted into the patient about 20cm.The physician withdrew it outside of the body.Changed the product to a competitor¿s brand device and the procedure was completed.There was no patient injury.Target cerebral position was not lost.An angiographic image was provided along with two pictures of the product packaging.

Manufacturer Narrative

Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a percutaneous intracavitary thrombectomy of cerebrovascular vessels, the external part of the delivery wire of a 4.5mm revive se thrombectomy device (frs21452299, l15943) was ¿broken¿.The delivery wire was broken outside of the patient¿s body when its far-end was implanted into the patient about 20cm.The physician withdrew it outside of the body.Changed the product to a competitor¿s brand device and the procedure was completed.There was no patient injury.Target cerebral position was not lost.No additional information is available.An angiographic image and two images of the product packaging was received.There is no information about the catheter used when they attempted to deliver the revive se or how they prepared the device, such as whether the catheter was on a flush or not.There is no information about the device itself when it was removed, such as if it was damaged or not.Stent retrievers in general can require a modicum of force to deliver and if the doctor is not careful to deliver the forces required along the axis of the pusher wire, the wire can bend or break.However, given the paucity of information, it is challenging to conclude anything concrete from this case.A manufacturing record evaluation was performed for the finished device l15943 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿delivery wire - separated - in patient¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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: 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: 10132864
• MDR Text Key: 202357528
• Report Number: 3008114965-2020-00237
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: FRS21452299
• Device Lot Number: L15943
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1