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

Model Number	U357564
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Insert (1316); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
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.(expiry date: 07/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had difficulty being deflated and failed to be inserted through the sheath at the second attempt.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had difficulty being deflated and failed to be inserted through the sheath at the second attempt.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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: one ultraverse 035 pta dilatation catheter connected to an unknown inflation device has been received for the evaluation.On the visual evaluation, the returned unknown introducer sheath was noted to have a damage at the distal tip and it was also examined under the microscopic observation.No other anomalies were noted.On the functional evaluation, an in-house guidewire lumen and an in-house introducer sheath were flushed, balloon was loaded onto the guidewire, then inserted into the introducer sheath without issue.On further, the balloon was inflated with the returned inflation device, maintained pressure without issue.The balloon deflated approximately at five seconds without issue and retracted from introducer sheath with out any issue.No other functional testing was performed.Therefore the investigation for the reported deflation issue was unconfirmed as the balloon was deflated successfully without any issue and the deflation time was within the product specification limit.The investigation for the reported difficult to insert and device-device incompatibility was unconfirmed as the balloon was successfully inserted into the sheath without any issue.A definitive root cause for the reported deflation issue, difficult to insert and the device-device incompatibility could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023),.

• 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: 12445058
• Report Number: 2020394-2021-01639
• Device Sequence Number: 3382807
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMEV0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1