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

Model Number	U4150330RX
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records 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: 06/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the shaft of the catheter was allegedly bent.It was further reported that the vessel allegedly ruptured.The procedure was completed by using another device.The patient current status was unknown.
Additional 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 ultraverse rx pta dilatation catheter has been received for the evaluation.On the visual evaluation, the sample was noted bloody and a twist was noted at the inner guidewire lumen at the distal end of the balloon and no bend was noted at the catheter shaft.The guidewire needle was returned and no bend was noted, no other anomalies were noted to the sample.On the functional evaluation, the balloon was inflated using an in-house presto inflation device and the balloon was able to maintain the shape and pressure at 8 atm.Then the pressure was raised to 15atm and this time the shape was noted to be uniform through out but the balloon was found to be curvy upon inflation.On further the balloon was deflated and the inner guidewire lumen was straight and no bends was noted.No other functional testing was performed.Therefore the investigation for the reported material twist and material deformation was confirmed as the balloon was noted to be twisted and deformed during the sample evaluation.A definitive root cause for the reported material twist and the material deformation 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: 06/2023), g3, h6 (method) h11: h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the shaft of the catheter was allegedly bent.It was further reported that the vessel allegedly ruptured.The procedure was completed by using another device.The patient current status was unknown.

• Brand Name: ULTRAVERSE RX 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: 12098298
• Report Number: 2020394-2021-01266
• Device Sequence Number: 3782481
• Product Code: LIT
• UDI-Device Identifier: 00801741057045
• UDI-Public: (01)00801741057045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: U4150330RX
• Device Catalogue Number: U4150330RX
• Device Lot Number: CMEU0636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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