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

Model Number	AT120124
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	03/25/2021
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon was allegedly difficult to remove from the sheath.Reportedly the balloon and sheath were removed and used another device to complete the procedure.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 atlas pta dilatation catheter has been returned for the evaluation.On the visual evaluation the device was note to be bloody.The distal tip of the cordis sheath was noted to be buckled.No other anomalies were noted to the device.On the functional evaluation, the sheath was pulled proximally on the sample to remove the balloon.No evidence of damaged to the balloon was noted.On further the balloon was inflated using an in-house presto inflation device then the balloon was successfully inflated and deflated without any issues.Deflation time was noted to be within product performance specifications.No further testing was performed.One photo was reviewed.The photo consists of two different devices in two different pouches.The left side pouch shows the vaccess device which doesn't belongs to this complaint and therefore no information was included.The right side pouch shows the atlas device and this device belongs to this complaint.The balloon was noted to be loaded into the unknown sheath, no other specific anomalies were noted.Therefore based on the photo review , the reported difficult to remove can be confirmed as the balloon was noted to be loaded into the unknown sheath.However the reported deflation issue remains inconclusive as no evidence was noted on the submitted photo.Therefore the investigation is unconfirmed for the reported deflation issue, as the device was able to be deflated and the deflation time was noted to be within product performance specifications.The investigation is confirmed for the reported difficult to remove, as the balloon loaded with the unknown sheath on the device returned for the evaluation.A definitive root cause for the reported deflation issue and difficult to remove 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.H11: section a through f ¿ the information provide 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, the pta balloon allegedly failed to deflate.It was further reported that the balloon was allegedly difficult to remove from the sheath.Reportedly the balloon and sheath were removed and used another device to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS 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: 12007817
• Report Number: 2020394-2021-01212
• Device Sequence Number: 3304715
• Product Code: DQY
• UDI-Device Identifier: 00801741062605
• UDI-Public: (01)00801741062605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: AT120124
• Device Catalogue Number: AT120124
• Device Lot Number: GFFN2233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/17/2021
• 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
• Patient Age: 52 YR
• Patient Weight: 88