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

Model Number	U357598
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure of a left basilic fistula, the pta balloon catheter allegedly had difficulty being deflated after being inflated to 12 atm on the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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.The device was returned for evaluation.A visual inspection did not find any deflation related defects with the device.The device was inflated with an in-house inflation device, and was inflated to the rated burst pressure.Upon deflating the balloon, it was noted that the balloon was able to fully deflate.Balloon deflation was within the specified time constraints for this device.Therefore, the investigation is unconfirmed for the reported deflation issue, as the returned device deflated within the expected time constraint during functional testing.Although the balloon was able to be fully deflated, decreased fluid flow was experienced due to a partial occlusion of the inflation lumen at the proximal balloon bond.This decreased fluid flow would be perceived by the user as slower than expected deflation times.However, this decrease in fluid flow did not prohibit the balloon from being fully inflated or deflated, as the deflation time was well within the required time constraint.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter is a single unit.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention (b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure of a left basilic fistula, the pta balloon catheter allegedly had difficulty being deflated after being inflated to 12 atm on the third inflation attempt.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6805145
• Report Number: 2020394-2017-00984
• Device Sequence Number: 16422935
• Product Code: LIT
• UDI-Device Identifier: 00801741094361
• UDI-Public: (01)00801741094361
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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 Expiration Date: 05/21/2018
• Device Model Number: U357598
• Device Catalogue Number: U357598
• Device Lot Number: 50124052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 76