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

Model Number	U3513084
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 the during an angioplasty procedure in a a/v fistula, the pta balloon catheter allegedly ruptured past rated burst pressure.Reportedly, the pta balloon allegedly became stuck inside the 6fr sheath during retraction.It was further reported that when the balloon and sheath were removed from the patient, a segment of the balloon material allegedly detached.The patient was sent to surgery for removal of the detached balloon segment.The patient was reported to be doing well post surgery.
Additional Manufacturer Narrative
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.The device was returned for evaluation.A visual inspection found a complete detachment of the balloon and inner guidewire lumen.Additionally, the device was returned inserted through the user's introducer sheath.The distal tip of the sheath was buckled.Therefore, the investigation is confirmed for both balloon and catheter detachment, as well as sheath-related retraction issues based on the buckled sheath tip.However, the investigation is inconclusive for the reported rupture, as the balloon was not returned in its entirety and was unable to be inflated to examine for ruptures.It is likely that the excessive force exerted on the device resulted in the identified balloon detachment.It is possible that a balloon rupture could have resulted in the reported retraction issue.However, the definitive root cause for the balloon becoming stuck in the sheath or the reported balloon rupture could not be determined based upon available information.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 the during an angioplasty procedure in a a/v fistula, the pta balloon catheter allegedly ruptured past rated burst pressure.Reportedly, the pta balloon allegedly became stuck inside the 6fr sheath during retraction.It was further reported that when the balloon and sheath were removed from the patient, a segment of the balloon material allegedly detached.The patient was sent to surgery for removal of the detached balloon segment.The patient was reported to be doing well post surgery.

• Brand Name: ULTRAVERSE 035 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: 7390848
• Report Number: 2020394-2018-00330
• Device Sequence Number: 1339489
• Product Code: LIT
• UDI-Device Identifier: 00801741094170
• UDI-Public: (01)00801741094170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/02/2018

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: U3513084
• Device Catalogue Number: U3513084
• Device Lot Number: CMBV0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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