MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ROTAREX SET 6F 135CM; THROMBECTOMY & ATHERECTOMY

Catalog Number 80237

Device Problems Break (1069); Melted (1385); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

The fda rn number and manufacturing location for the straub product was selected as 2020394 and unknown due to system limitations.The correct fda rn number and manufacturing location are 3008439199 and straub medical us.As the lot number for the device was provided, a review of the device history records will be 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 to treat the mid sfa, the device allegedly got separated from the catheter and broke inside the patient.Reportedly, an arteriotomy was performed to extract the device; however, the current status of the patient is unknown.

Event Description

It was reported that during a procedure to treat the mid sfa, the device allegedly got separated from the catheter and broke inside the patient.Reportedly, an arteriotomy was performed to extract the device; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The physical investigation showed that the tube was kinked 84 cm distal twice with holes in the tube.The helix was separated at 40 cm distal.The kink of the tube and the helix break did not correlate.It is assumed that the catheter kinked outside the body due to improper handling.This lead to a damage of the tube (holes) and diminished aspiration capacity.While running dry the catheter heated up what finally caused the helix break inside the patient body.Therefore, the investigation is confirmed for the reported material separation, break, detachment and melted 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 fda rn number and manufacturing location for the straub product was selected as 2020394 and unknown due to system limitations.The correct fda rn number and manufacturing location are 3008439199 and straub medical us.H10: d4 (expiry date: 07/2023).H11: h6 (method, result, conclusion).H11: section a through f: the information provide by bd represents all 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.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.The physical investigation showed that the tube was kinked 84 cm distal twice with holes in the tube.The helix was separated at 40 cm distal.The kink of the tube and the helix break did not correlate.It is assumed that the catheter kinked outside the body due to improper handling.This lead to a damage of the tube (holes) and diminished aspiration capacity.While running dry the catheter heated up what finally caused the helix break inside the patient body.Therefore, the investigation is confirmed for the reported material separation, break, detachment and melted 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 fda rn number and manufacturing location for the straub product was selected as 2020394 and unknown due to system limitations.The correct fda rn number and manufacturing location are 3008439199 and straub medical us.H10: (expiry date: 07/2023) h11: section a through f: the information provide by bd represents all 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 procedure to treat the mid sfa, the device allegedly got separated from the catheter and broke inside the patient.Reportedly, an arteriotomy was performed to extract the device; however, the current status of the patient is unknown.

• Brand Name: ROTAREX SET 6F 135CM
• Type of Device: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11855324
• MDR Text Key: 251728854
• Report Number: 2020394-2021-01076
• 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,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 201041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention