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

Model Number	U35130104
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional 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.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly failed to inflate.It was further reported that the another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultraverse 035 pta dilatation catheter was returned for the evaluation.Visual evaluation was performed and noted that catheter was bloody near the strain relief but the balloon appeared clean and pleated.During the functional test, the balloon was inflated using an in-house presto inflation device, but it was noted water was exiting from the middle portion of the balloon.Then microscopic evaluation was performed and balloon rupture was noted.It was a longitudinal balloon rupture.Therefore, the investigation is confirmed for the reported inflation problem, as the balloon did not inflate due to the balloon rupture.The investigation is confirmed for the identified balloon rupture, as longitudinal balloon rupture was noted during the microscopic evaluation.Although it is likely the balloon rupture led to the inflation problem.A definitive root cause for the inflation problem and balloon rupture 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: 06/2022), g3 h11: h6 (result and 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.See h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly failed to inflate.It was further reported that the another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11523626
• Report Number: 2020394-2021-00607
• Device Sequence Number: 17486316
• Product Code: LIT
• UDI-Device Identifier: 00801741094705
• UDI-Public: (01)00801741094705
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: U35130104
• Device Catalogue Number: U35130104
• Device Lot Number: CMDU0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR