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

Model Number	U357574
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
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.
Event or Problem Description
It was reported that during an angioplasty procedure of an upper arm fistula, an alleged pinhole rupture occurred and was subsequently difficult to retract through the 7fr sheath.The balloon and sheath were removed together as one unit through a larger sheath.The health care provider sutured the access site and applied pressure to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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.Conclusion: the device was returned for evaluation.A visual inspection found a complete circumferential rupture in the balloon, as well as a complete detachment of the inner guidewire lumen.Therefore, the investigation is confirmed for a circumferential rupture, as well as for balloon and catheter detachment.The proximal marker band was found to have detached from the inner guidewire lumen, so the investigation is confirmed for marker band detachment as well.Based on the bunching of the balloon material and stretching noted to the inner guidewire lumen, the investigation is confirmed for the reported retraction issues through the sheath.The investigation is inconclusive for the reported pinhole rupture as the balloon not able to be inflated due to the device damage.The balloon rupture likely lead to the retraction issue and detachments.However, the definitive root cause for the balloon rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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 felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.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 as 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.
Event or Problem Description
It was reported that during an angioplasty procedure of an upper arm fistula, an alleged pinhole rupture occurred and was subsequently difficult to retract through the 7fr sheath.The balloon and sheath were removed together as one unit through a larger sheath.The health care provider sutured the access site and applied pressure 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: 6818243
• Report Number: 2020394-2017-01016
• Device Sequence Number: 121442
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 05/31/2020
• Device Model Number: U357574
• Device Catalogue Number: U357574
• Device Lot Number: CMBT0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 136