MAUDE Adverse Event Report: UNKNOWN ROTAREX SET 6F 135CM; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Perforation (2001); Pseudoaneurysm (2605)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2023).

Event Description

It was reported that during a procedure through antegrade access in the mid anterior tibial artery, the device allegedly failed to advance and the wire remains stuck in the catheter.It was further reported that guidewire was allegedly detached inside the patient and the detached fragment was snared.Upon angiogram, a large perforation was noted to distal sfa.The patient experiences pseudoaneurysm and a covered stent was placed to cover lesion.The patient was reportedly stable.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive for the reported issues.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported that during a procedure, the wire allegedly failed to advance and wire remains stuck in the catheter.It was further reported that guidewire allegedly detached inside the patient.Detached fragment was snared.Reportedly pseudoaneursym was noted and a covered stent was placed to cover lesion.The patient was reportedly stable.

• Brand Name: ROTAREX SET 6F 135CM
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• MDR Report Key: 12251344
• MDR Text Key: 264265111
• Report Number: 3008439199-2021-00125
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80237
• Device Lot Number: 200969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR