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

Catalog Number	ATG80184
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during an angioplasty procedure in the left common iliac artery, the pta balloon allegedly ruptured at rated burst pressure.It was further reported that the balloon could not be deflated and had difficulty retracting.A needle stick was allegedly used to deflate the device.Another device was used to complete the procedure.The patient was reportedly asymptomatic.
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device, inserted in an introducer sheath, was returned for evaluation.A visual inspection found a break at the proximal weld break, with the balloon folded over the distal tip of the device.Therefore, the investigation is confirmed for a proximal weld break.Additionally, stretching was noted to the inner guidewire lumen and the distal tip of the attached introducer sheath was flared.Based on the folded over balloon, the stretching to the inner lumen, and the damage to the sheath, the investigation is confirmed for sheath related retraction issues.However, the investigation is inconclusive for the reported deflation issue and rupture as the device was unable to be functionally tested due to the damage.Based on the condition of the returned sample, it is likely that resistance was encountered by the user leading to excessive force being applied to the device as it was being withdrawn through the sheath.This excessive force may have led to the balloon breaking from the shaft.However, the definitive root cause for the identified retraction issue and reported deflation and rupture 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.(expiry date: 07/2021), (trending device code: 1069 - break).
Event or Problem Description
It was reported that during an angioplasty procedure in the left common iliac artery, the pta balloon allegedly ruptured at rated burst pressure.It was further reported that the balloon could not be deflated and had difficulty retracting.A needle stick was allegedly used to deflate the device.Another device was used to complete the procedure.The patient was reportedly asymptomatic.

• 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: 7976031
• Report Number: 2020394-2018-01916
• Device Sequence Number: 19252907
• Product Code: LIT
• UDI-Device Identifier: 00801741060878
• UDI-Public: (01)00801741060878
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• 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): 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ATG80184
• Device Lot Number: 93UC0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 03/08/2019
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 105