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

Model Number	U357594
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly stuck and unable to remove.It was further reported that the shaft of the catheter allegedly broke.The balloon and the sheath were removed together as one unit.There was no reported patient injury.
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 partially detached ultraverse 035 pta catheter and the balloon loaded within the introducer sheath has returned for evaluation.On the visual evaluation of the device, it appeared bloody and introducer sheath found bunched at proximal end.The catheter was in detached condition and the balloon is still stuck within the introducer sheath.On the functional evaluation of the device, the introducer sheath was flushed without any issue.Attempts were made to push the catheter and balloon, but it was unsuccessful.On further the sheath was cut longitudinally along the length to remove the balloon.The balloon was still intact with the catheter.The distal and the proximal end of the balloon was examined under microscope and it was noted damaged.No evidence of break noted to the device.No further evaluation performed due to the condition of the device.Therefore, the reported detachment has confirmed as the partial catheter with balloon still intact has returned for evaluation.The investigation also confirmed for retraction issue, as the balloon couldn¿t retracted through the introducer sheath, it was removed by cutting the sheath along the length.The investigation remains inconclusive for the reported break as no evidence was noted to the device returned for evaluation.A definitive root cause for the reported break, detachment of device and retraction issue could not be determined based upon the provided information.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: 09/2022).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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly stuck and unable to remove.It was further reported that the shaft of the catheter allegedly broke.The balloon and the sheath were removed together as one unit.There was no reported patient injury.

• 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: 11123016
• Report Number: 2020394-2020-21034
• Device Sequence Number: 11913853
• Product Code: LIT
• UDI-Device Identifier: 00801741094347
• UDI-Public: (01)00801741094347
• 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): 03/08/2021

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: U357594
• Device Catalogue Number: U357594
• Device Lot Number: CMDX0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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