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

Model Number	U415038RX
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	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no 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 not 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 the pta balloon allegedly ruptured.Reportedly, balloon segments detached from the balloon catheter and the use of a snare device was used to recover the balloon segments successfully.Reportedly, the balloon and sheath were removed together as one unit.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.Investigation summary: the device was returned for evaluation.A visual inspection found the device returned detached in multiple locations.A total of five device segments were returned, making up the entire device.The balloon was also noted to be detached at the proximal balloon weld joint.Therefore, the investigation is confirmed for both catheter and balloon detachments.The original sheath used with the device was not returned, and the device was unable to be functionally tested due to the returned sample condition.Therefore, the investigation is inconclusive for the reported balloon rupture, and sheath-related retraction issues.It is possible that retraction issues could have led to the identified catheter detachments.However, the definitive root cause for the identified detachments or reported rupture and sheath-related retraction issue could not be determined based upon available information.It is unknown whether procedural issues or the original sheath used in the procedure 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 the pta balloon allegedly ruptured.Reportedly, balloon segments detached from the balloon catheter and the use of a snare device was used to recover the balloon segments successfully.Reportedly, the balloon and sheath were removed together as one unit.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX 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: 7456957
• Report Number: 2020394-2018-00478
• Device Sequence Number: 19202870
• Product Code: LIT
• UDI-Device Identifier: 00801741056864
• UDI-Public: (01)00801741056864
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 10/31/2019
• Device Model Number: U415038RX
• Device Catalogue Number: U415038RX
• Device Lot Number: CMAY0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 70