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

Model Number	U41502H4RX
Medical Device Problem Codes	Material Discolored (1170); Leak/Splash (1354); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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.However, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly leaked.It was further reported that the catheter was discolored and unable to deliver over guidewire.There was no reported patient injury.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the balloon of the device allegedly detached and leaked.It was further reported that the balloon had incompatibility issue and catheter was allegedly discolored.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one device was returned for evaluation.The device was visually evaluated and the inner guidewire along with the marker bands was noted to be missing in the returned sample.The length of the returned device was measured.The detachment was noted to be from the proximal glue joint under magnification.No further functionality testing could be carried out due to the condition of the device.One electronic photo was reviewed.The photo shows the distal end of the device with the balloon protector noted to be over the device.Based on the photo review, no failure mode confirmations could be made.Therefore, the investigation is confirmed for device detachment as the distal portion of the device was noted to be missing.The investigation is also confirmed for the material discoloration as the inner lumen was noted to be missing from the device.The investigation is inconclusive for the reported leak and device incompatibility, as no functionality testing could be carried out due to the condition of the device.The device detachment most likely contributed to the reported material discoloring.The device detachment most likely contributed to the reported device leak as well.However, the definitive root cause for the reported device incompatibility, device leak, material discoloration and identified device detachment could not be determined.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 02/2023),g3,h6(method).H11: b5,e1,h6(result and conclusion).H11: section a through f: the information provide by bd represents all 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 bd.

• 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: 11669876
• Report Number: 2020394-2021-00856
• Device Sequence Number: 14200098
• Product Code: LIT
• UDI-Device Identifier: 00801741056475
• UDI-Public: (01)00801741056475
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2021

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: U41502H4RX
• Device Catalogue Number: U41502H4RX
• Device Lot Number: CMEQ0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/21/2021
• 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: Other