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

Model Number	U3513046
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Puncture/Hole (1504); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos and a video 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 in superficial femoral artery, the leakage was identified in the body of the balloon.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in superficial femoral artery, the leakage was identified in the body of the balloon.It was further reported that the device had difficulty to removing and not possible to inflate again.Upon removing noticed it had grooves in body and had a hole in device.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: the physical device was not returned for evaluation.However, three photo were submitted for review.All three photos showed the crimp mark of the stent imprinted on the catheter, no other anomalies were noted.Therefore, based on the photo review, the reported leak, inflation issue, difficult to remove, material tear and material deformation not be confirmed on the findings no conclusion can be made.One video was reviewed.The video showed water leaking from the catheter shaft which contain the groove in the shaft and the balloon appeared to be in a deflated state, no other anomalies were noted.Therefore, based on the video review, the reported failure leak, inflation issue ,material deformation and material tear/hole can be confirmed for.Medical review was completed to two of the images.Both the images showed the pelvis region of the left femoral artery system from the right femoral artery and also the balloon catheter and sheath in the left iliac artery.Contrast is seen outlining the proximal femoral artery and distal and also the a short segment narrowing of the left proximal femoral artery at the level of the left total hip.No findings on the image to suggest balloon rupture.Based on the medical review, no failure mode can be confirmed for as the findings were inconclusive.Although it is likely the groove on the catheter shaft led to the to the difficult to remove and the rupture most likely contributed to the reported leak.A definitive root cause for the alleged leak, inflation issue, difficult to remove, material puncture and material deformation 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: 02/2023).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.H3 other text : device not returned.

• 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: 10814979
• Report Number: 2020394-2020-20396
• Device Sequence Number: 11044525
• Product Code: LIT
• UDI-Device Identifier: 00801741092183
• UDI-Public: (01)00801741092183
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/12/2021

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: U3513046
• Device Catalogue Number: U3513046
• Device Lot Number: CMEQ0112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 05/21/2021
• 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