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

Model Number	U4200220RX
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation and a photo was provided, therefore 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 pta balloon allegedly broke upon completion of the angioplasty procedure, segments of the balloon and catheter remained in the patient.Reportedly, a snare was used to remove the segment, however it was unsuccessful.After four hours, the detached segment was cut down and removed from the patient.The patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.As the conditions of use could not be fully recreated (e.G.Patient vessel), the investigation is inconclusive for the reported advancement issues and failure to cross the target lesion.A visual inspection found a break in the catheter and balloon at the distal end of the balloon with the distal tip of the balloon missing.Therefore, the investigation is confirmed for the reported catheter and balloon break and confirmed for the identified catheter and balloon detachment.A visual inspection also found that the inflation hub was missing from the proximal end of the device.Therefore, the investigation is confirmed for the identified inflation hub detachment.One electronic photo was provided for review.The photo shows the ultraverse rx device in a clear package with a portion of the label visible referencing catalog number u4200220rx and lot number cmdu0361.Based on the photo review, no anomalies can be noted.Per the reported event details, the alleged catheter and balloon break likely led to the identified detachment of the distal end of the catheter and balloon.However, the definitive root cause for the reported failure to cross target lesion, reported catheter break and balloon break, identified balloon and catheter detachment, or identified inflation hub detachment could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 in the left posterior tibial artery, the pta balloon allegedly had difficultly crossing the lesion.It was further reported that the device broke upon completion of the angioplasty procedure, segments of the balloon and catheter remained in the patient.Reportedly, a snare was used to remove the segment, however it was unsuccessful.After four hours, the detached segment was cut down and removed from the patient.The patient is reportedly stable.

• 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: 8971108
• Report Number: 2020394-2019-03148
• Device Sequence Number: 2610161
• Product Code: LIT
• UDI-Device Identifier: 00801741056338
• UDI-Public: (01)00801741056338
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: U4200220RX
• Device Catalogue Number: U4200220RX
• Device Lot Number: CMDU0361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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