MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number VERSION 1.0

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported that during a recanalization procedure in the superficial femoral artery via a contralateral approach, the catheter allegedly got caught and fused together with the wire.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.

Manufacturer Narrative

H10: manufacturing review: the lot number of the catheter set is unknown and therefore a manufacturing review was not performed.Investigation summary: the sample was not returned to the manufacturer for evaluation and images were not provided for review.The investigation is inconclusive for reported issues.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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.H10: g3, h6 (device).H11: h6 (result, conclusion).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 recanalization procedure in the superficial femoral artery via a contralateral approach, the catheter allegedly got caught and fused together with the wire.There was no reported patient injury.

Manufacturer Narrative

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.H10: manufacturing review: the lot number of the catheter set is unknown and therefore a manufacturing review was not performed.Investigation summary: the sample was not returned to the manufacturer for evaluation and images were not provided for review.The investigation is inconclusive for reported issues.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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.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.

Event Description

It was reported that during a recanalization procedure in the superficial femoral artery via a contralateral approach, the catheter allegedly got caught and fused together with the wire.The procedure was completed using another guidewire.There was no reported patient injury.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13729230
• MDR Text Key: 288872527
• Report Number: 3008439199-2022-00014
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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 Model Number: VERSION 1.0
• Device Catalogue Number: 80237
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 03/13/2023
• Supplement Dates FDA Received: 04/06/2022; 03/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female