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

Catalog Number	V1840150
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, after dilation the pta balloon allegedly could not be removed from the body.There was no reported patient 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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025) 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.
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: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows the vascutrak device placed on a plain surface.Guidewire is loaded in the balloon.No other anomalies noted.Therefore, the investigation remains inconclusive for the reported removal difficulty and deflation problem as no objective evidence was provided for review.A definitive root cause for the alleged removal difficulty and deflation problem could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery, it was found that the pta balloon allegedly could not be removed from the body.It was further reported that the pta balloon was withdrawn from the body after an alleged extracorporeal puncture of the balloon with a micro penetrating needle under the contrast medium to relieve the pressure.There was no reported patient injury.

• Brand Name: VASCUTRAK
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20276688
• Report Number: 2020394-2024-01454
• Device Sequence Number: 20804793
• Product Code: PNO
• UDI-Device Identifier: 00801741061585
• UDI-Public: (01)00801741061585(17)251228(10)GFGW1577
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Expiration Date: 12/28/2025
• Device Catalogue Number: V1840150
• Device Lot Number: GFGW1577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown