MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U8130630
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/01/2020
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.However a photo and image are provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure through common femoral artery, the pta balloon allegedly had a pinhole rupture at 4 atm.However, the stent dissected area to resolve.It was further reported that another balloon was used to complete the procedure.The patient status is unknown.
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 018 pta device has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no other specific anomalies noted.On the functional evaluation of the device, on inflating the balloon with an in-house presto inflation device a pin-hole rupture has noted.On the microscopic observation the balloon a pin hole rupture has confirmed.Two images reviewed.The first image shows the inflated balloon with contrast and also noted a dense calcification, the image doesn't show any pin hole rupture, the second image shows the with contrast in an inflated balloon in the distal sfa.There is more contrast along the lateral aspect of the vessel where the balloon was inflated consistent with dissection of contrast into the soft tissues.The appearance could be seen with a pinhole tear of the balloon.Therefore, based on the image review, the reported failure balloon rupture can be confirmed.However, the definitive root cause for the reported balloon rupture could not be determined based upon available 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: 03/2023), g3.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.
Event or Problem Description
It was reported that during an angioplasty procedure through common femoral artery, the pta balloon allegedly had a pinhole rupture at 4 atm.However, the stent dissected area to resolve.It was further reported that another balloon was used to complete the procedure.The patient status is unknown.

• Brand Name: ULTRAVERSE 018 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: 10709816
• Report Number: 2020394-2020-20184
• Device Sequence Number: 19653583
• Product Code: LIT
• UDI-Device Identifier: 00801741064654
• UDI-Public: (01)00801741064654
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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): 03/23/2021

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: U8130630
• Device Catalogue Number: U8130630
• Device Lot Number: CMER0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 04/08/2021
• 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