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	Perforation of Vessels (2135)
Date of Event	09/15/2020
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 ruptured at 6 atm.However perforation of the popliteal vessel was resolved with balloon tamponade.It was further reported that another balloon was used to complete the procedure.The patient status was unknown.
Event or Problem Description
It was reported that during an angioplasty procedure through common femoral artery, the pta balloon allegedly ruptured at 6 atm.However perforation of the popliteal vessel was resolved with balloon tamponade.It was further reported that another balloon was used to complete the procedure.The patient status was 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 was returned for evaluation.Three of medical images were provided for review.There appears to be extravasation from the below knee popliteal artery segment as well as numerous areas of arterial dissection.It is unclear from the images the sequence of events that led to this.Based on the image review, the reported balloon rupture cannot be confirmed.The sample was bloody within the balloon, no other anomalies was noted.The device was functionally tested using an in-house inflation device and a pinhole rupture was noted.Therefore the investigation is confirmed for the reported balloon rupture.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 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.

• 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: 10709732
• Report Number: 2020394-2020-20181
• Device Sequence Number: 16964296
• 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): 03/30/2021

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: 03/30/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 04/09/2021
• 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