MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Model Number	U41502H22
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 014 pta dilatation catheter was returned for evaluation.The returned device was noted to be loaded on to unknown.014" guidewire.During visual examination, bunching was noted throughout the catheter shaft and balloon.An opaque material was noted at the distal tip of the balloon, which is noted to be separated from the inner lining of the guidewire lumen.The opaque material is magnified under microscope.No other anomalies were noted to the sample.During functional testing, an attempt was made to remove the guidewire, but was unsuccessful.The investigation was confirmed for the reported device-device incompatibility and identified material separation, as an opaque material was noted at the distal tip of the balloon.The investigation was confirmed for the reported difficult to remove as guidewire was not able to be removed from the catheter during functional testing.The opaque material noted during evaluation most likely contributed to the reported device incompatibility and difficult to remove.The definitive root cause for the reported device incompatibility, difficult to remove and identified material separation could not be determined based upon available 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.(expiry date: 01/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck on the guidewire and difficult to remove from the patient.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• MDR Report Key: 12376592
• Report Number: 2020394-2021-01514
• Device Sequence Number: 4115618
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMFP0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1