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

Model Number	U35130315
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 04/2023).
Event or Problem Description
It was reported that during an angiogram of the right lower extremity, the pta balloon allegedly ruptured.It was further reported that a foreign body was removed along with the balloon as a whole unit.The patient's current status was unknown.
Additional Manufacturer Narrative
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 ultraverse 035 pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, the returned in two segments where the first segment consist of detached balloon without the inner guide wire lumen.The distal tip was bunched within the balloon and one marker band was present within the balloon and the second segment consist of the remaining balloon and catheter and inner guide wire lumen.All the anomalies can be able to confirm under the microscopic observation.No other functional evaluation performed due to the condition of the device.Therefore, the investigation is confirmed for the reported balloon rupture as the compound rupture has noted to the device returned for evaluation.The investigation is also confirmed for the identified detachment of device as the device returned for evaluation in two segments.A definitive root cause for the alleged balloon rupture and identified detachment of device 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.Expiry date: 04/2023 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 or Problem Description
It was reported that during an angiogram of the right lower extremity, the pta balloon allegedly ruptured.It was further reported that a foreign body was removed along with the balloon as a whole unit.The patient's current status was unknown.

• 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: 11397348
• Report Number: 2020394-2021-00395
• Device Sequence Number: 4503412
• Product Code: LIT
• UDI-Device Identifier: 00801741091728
• UDI-Public: (01)00801741091728
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U35130315
• Device Catalogue Number: U35130315
• Device Lot Number: CMES0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 56