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

Model Number	U357564
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/12/2019
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.The investigation of the reported event is currently underway.(expiry date: 01/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the right common iliac, the pta balloon allegedly ruptured.It was further reported that the balloon was allegedly stuck and detached from the catheter upon removal.Reportedly, medical intervention was required to remove the detached segment from the patient within a different access site using a snare device.There was no reported patient injury.The patient was reportedly discharge post procedure.
Event or Problem Description
It was reported that during an angioplasty procedure in the right common iliac, the pta balloon allegedly ruptured.It was further reported that the balloon was allegedly stuck and detached from the catheter upon removal.Reportedly, medical intervention was required to remove the detached segment from the patient within a different access site using a snare device.There was no reported patient injury.The patient was reportedly discharge post procedure.
Additional Manufacturer Narrative
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.A visual inspection was performed and the balloon was noted to be circumferentially ruptured with only the proximal portion of the balloon remaining.The inner lumen was noted to be broken and detached near the proximal end of the balloon.The distal portion of the inner lumen and the distal portion of the balloon were not returned.No other anomalies were noted to the device.No functional testing was performed due to the condition of the device.Therefore, the investigation is confirmed for the reported balloon rupture, as the balloon was noted to be circumferentially ruptured with only the proximal portion of the balloon remaining.The investigation is confirmed for the balloon and inner lumen detachment, as the distal portion of the inner lumen and the distal portion of the balloon were detached from the device and not returned.The balloon rupture likely led to the detachment issues.However, the definitive root cause for the balloon rupture, balloon detachment and lumen detachment could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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.

• Brand Name: ULTRAVERSE 035 PTA 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: 8876190
• Report Number: 2020394-2019-02376
• Device Sequence Number: 14087542
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMDP0406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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: 60 YR
• Patient Weight: 100