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

Model Number	VA8074
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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: 07/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the upper arm, the pta balloon allegedly ruptured at 20 atm, on the second inflation attempt.It was further reported that during removal of the device, balloon material detached and migrated to the heart.The patient was transported to the hospital for retrieval of the detached material.The patient is reportedly stable.
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, as this is the first complaint for the reported lot number.Investigation summary: the device was returned for evaluation.A visual inspection was performed.The sample appeared to be clean.The balloon and the distal tip of the catheter were noted to be detached but were not included in the returned package.The marker bands were still present on the catheter.The guidewire lumen was noted to be exposed.The glue bullet was noted to be pulled from its original position.Remains of balloon material were noted at the proximal balloon joint.The returned segment measured approximately 81.4cm from the strain relief to the break.No further functional testing or evaluations were performed due to the state of the device.Therefore, the investigation is confirmed for the reported balloon detachment, as the balloon noted to be detached from the catheter was not returned for evaluation.The investigation is inconclusive for the reported balloon rupture, as the balloon was not returned for evaluation.The reported balloon rupture may have contributed to the detachment issue.However, the definitive root cause for the reported balloon rupture, and 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the upper arm, the pta balloon allegedly ruptured at 20 atm, on the second inflation attempt.It was further reported that during removal of the device, balloon material detached and migrated to the heart.The patient was transported to the hospital for retrieval of the detached material.The patient is reportedly stable.

• Brand Name: VACCESS 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: 9765816
• Report Number: 2020394-2020-01133
• Device Sequence Number: 16315829
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 04/30/2020

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: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93UD0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: Hospitalization