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

Model Number	U3513078
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported during an angioplasty procedure through left humeral artery in left external iliac artery, the device allegedly had retraction problem.It was further reported medical intervention was required to complete the procedure.The patient status was stable.
Event or Problem Description
It was reported during an angioplasty procedure through left humeral artery in left external iliac artery, the device allegedly had retraction problem.It was further reported medical intervention was required to complete the procedure.The patient status was stable.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and incidental stretching was noted to the device in the sheath.No other anomalies were noted to the device.The device was removed from the sheath and the device was not be received in two segments.Therefore, the investigation is confirmed for the reported retraction issue, as the device was returned stuck in a sheath with stretching noted to the device.The investigation is also confirmed for the detachment, as the device was received in two segments.The definitive root cause for the retraction issue and detachment could not be determined based upon available information.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.H10: d4 (expiry date: 03/2023).H11:section a through f - the information provided by bd 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 bd.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Common Device Name: PTA DILATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10337993
• Report Number: 2020394-2020-05207
• Device Sequence Number: 3178676
• Product Code: LIT
• UDI-Device Identifier: 00801741093692
• UDI-Public: (01)00801741093692
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: U3513078
• Device Catalogue Number: U3513078
• Device Lot Number: CMER0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 65