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

Model Number	VA8064R
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
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.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm, the pta balloon allegedly ruptured circumferentially.Reportedly, the health care provider made a larger incision to remove the balloon and sheath as one unit.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.The user's cordis 6fr sheath was also returned.A visual inspection found the catheter returned inserted through the sheath.A complete break to the proximal balloon bond was noted and the balloon material was bunched at the distal tip.The inner lumen was also noted to be stretched and with the proximal marker band dislodged.The user's sheath was also noted to be buckled and the damage was noted to the distal tip of the sheath.Therefore, the investigation is confirmed for a break at the proximal balloon joint, dislodgement of the proximal marker band, and sheath-related retraction issues.Although no circumferential rupture was noted in the balloon material, the investigation is conclusive for the reported rupture as the balloon was unable to be functionally tested due to the returned sample condition.It is possible that a rupture could have contributed to retraction issues through the sheath.Based on the returned sample condition, it is likely that retraction issues through the sheath contributed to the identified break and dislodgment.However, the definitive root cause for the reported rupture or identified retraction issue or break could not be determined based on the 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm, the pta balloon allegedly ruptured circumferentially.Reportedly, the health care provider made a larger incision to remove the balloon and sheath as one unit.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.

• 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: 8226690
• Report Number: 2020394-2018-02290
• Device Sequence Number: 2267028
• Product Code: DQY
• UDI-Device Identifier: 00801741059872
• UDI-Public: (01)00801741059872
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VA8064R
• Device Catalogue Number: VA8064R
• Device Lot Number: 93UC0146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1