MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U357584

Device Problems Retraction Problem (1536); Material Rupture (1546); Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).

Event Description

It was reported that during an angioplasty procedure through left forearm, the pta balloon allegedly ruptured.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure through left forearm, the pta balloon allegedly ruptured.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one photo was reviewed and it shows that the device separated into two segments at the proximal glue joint and got detached from one another.The first segment consist of the balloon and the portions prior to the proximal joint and the second segment consists of the rest of the catheter and the hub.Based on the photo review, the investigation for the reported detachment issue has been confirmed.One ultraverse 035 dilatation catheter in two segments has been returned for the evaluation.The first segment consists of the balloon that was broken at the proximal balloon joint and was noted to have a rupture.The segment two consists of the remaining catheter starting at the break at the proximal glue joint to the hub and no other specific anomalies were noted.No distal marker band was present in the device.Under microscopic observation, longitudinal rupture was noted.No other functional testing was performed.Therefore the investigation for the reported detachment of device has been confirmed as the device itself returned in two segments for the evaluation.The investigation for the identified material rupture has been confirmed as the longitudinal rupture was noted under the microscopic observation.The investigation has been confirmed for the identified marker band dislodgement as the distal marker was not present inside the device.However the investigation for the identified retraction problem has been inconclusive as the function testing was not performed and there is no evident for the retraction issue.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2023),g3 h11: e1, h6(device, result and 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.See h10.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11336777
• MDR Text Key: 232178371
• Report Number: 2020394-2021-00273
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (y/n): N
• PMA/PMN Number: K142261
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMEW0607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other