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

Catalog Number	ATG120164
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac vein and inferior vena cava, the pta balloon allegedly ruptured on the first inflation attempt.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.A visual inspection found a partial break at the proximal balloon weld.However, the balloon was not detached and no issues were noted to the distal balloon weld.Therefore, the investigation is confirmed for a break and is unconfirmed for the reported balloon detachment.The balloon was inflated and a pinhole rupture was noted on the proximal cone of the balloon.Therefore, the investigation is confirmed for the reported rupture.However, the investigation is inconclusive for the reported retraction issues as the balloon was unable to be refolded to it's original configuration due to the balloon damage.It is possible that the identified rupture could have contributed to the reported retraction issues.It is also possible that retraction issue could lead to the identified proximal weld break.However, the definitive root cause for the reported or identified issues could not be identified based on the 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.(b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac vein and inferior vena cava, the pta balloon allegedly ruptured on the first inflation attempt.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS GOLD 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: 7675001
• Report Number: 2020394-2018-01165
• Device Sequence Number: 16486376
• Product Code: LIT
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122984
• 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): 10/04/2018

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 Catalogue Number: ATG120164
• Device Lot Number: 93RC0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1