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

Model Number	AT75204
Medical Device Problem Codes	Inflation Problem (1310); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
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 sample was not returned to the manufacturer for evaluation; however, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, pta balloon allegedly had inflation issue.It was further reported that the balloon fiber allegedly unraveled.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned to the manufacturer for evaluation, five photos were submitted for review.The first four photos show the device outside of any packaging and the device is noted to be bloody.Unraveled fibers can be noted to the balloon portion of the device in all the photos.The fifth photo shows the device outside packaging of the device.The label refers to the product catalog number and lot number.Based on the photo review, the reported unraveled balloon fiber can be confirmed for as this was noted in the photo review.However, the investigation is inconclusive for the reported inflation issue as no sample as returned for evaluation.In the photo review conducted by the manufacturing review, the team concluded that the fiber unraveling most likely occurred during the procedure as no anomalies were noted during device preparation.It is likely that there was a small delamination of the pebax layer which allowed for the circumferential fiber to be caught on the refold tool, introducer or stent.This might have then caused the fibers to become unraveled causing the constriction of the balloon.However, the definitive root cause for the reported inflation issue and unraveled balloon fiber could not be determined based upon available 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: (expiry date: 03/2023).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.H3 other text: device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, pta balloon allegedly had inflation issue.It was further reported that the balloon fiber allegedly unraveled.The procedure was completed using another device.There was no patient contact.

• 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: 11312415
• Report Number: 2020394-2021-00221
• Device Sequence Number: 3711579
• Product Code: DQY
• UDI-Device Identifier: 00801741062520
• UDI-Public: (01)00801741062520
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/25/2021

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: AT75204
• Device Catalogue Number: AT75204
• Device Lot Number: GFEQ0439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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