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

Model Number	U4150210RX
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.Expiry date: 01/2021.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 of a stenotic lesion in the artificial blood vessel below the right knee, using an ipsilateral antegrade approach, the pta balloon catheter shaft detached and remained at the lesion site.It was further reported that there was difficulty retracting the balloon through the sheath.Reportedly, the health care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to surgically remove the detached segment.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of a stenotic lesion in the artificial blood vessel below the right knee, using an ipsilateral antegrade approach, the pta balloon catheter shaft detached and remained at the lesion site.It was further reported that there was difficulty retracting the balloon through the sheath.Reportedly, the heath care provider (hcp) attempted to retrieve the detached segment using a snare device but was unsuccessful.The hcp decided to surgically remove the detached segment.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation in two segments.A visual inspection found a detachment of the balloon and inner catheter shaft, confirming the device for the reported detachment.Additionally, the balloon and inner guidewire lumen were noted to be heavily bunched at the distal end of the balloon.Therefore, the investigation is confirmed for retraction issues.It is possible that retraction issues led to the identified detachments.However, the definitive root cause for the identified detachments or reported 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.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 01/2021.(b)(4).

• Brand Name: ULTRAVERSE RX 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: 7824380
• Report Number: 2020394-2018-01583
• Device Sequence Number: 16511053
• Product Code: LIT
• UDI-Device Identifier: 00801741056239
• UDI-Public: (01)00801741056239
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: U4150210RX
• Device Catalogue Number: U4150210RX
• Device Lot Number: CMCP0246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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: Required Intervention