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

Model Number	AT75184
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	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately ten years and four months later, a computed tomography (ct) abdomen and pelvis without contrast was performed and it revealed there was a caval perforation of 9 o'clock was 10.0mm, strut was bent posteriorly and superiorly and 6 o'clock was 9.2mm.Right sided tilt with 7.04-degrees.There was migration and the apex of the filter was at the level of the renal veins.Therefore, the investigation is confirmed for alleged filter migration, material deformation and perforation of the inferior vena cava.The definitive root cause 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon unable to deflate and cannot be removed from the sheath.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon unable to deflate and cannot be removed from the sheath.The procedure was completed using another 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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause 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: 04/2023).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: ATLAS PTA BALLOON 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: 11479186
• Report Number: 2020394-2021-00523
• Device Sequence Number: 17094839
• Product Code: DQY
• UDI-Device Identifier: 00801741062490
• UDI-Public: (01)00801741062490
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K120971
• 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: AT75184
• Device Catalogue Number: AT75184
• Device Lot Number: GFER2581
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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