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

Model Number	ATG80186
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be 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 of a calcified lesion in the left common iliac vein the pta balloon allegedly ruptured at 10atm during the fourth inflation attempt.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation in the user's introducer sheath.A visual inspection found a complete break at the proximal balloon weld joint.The inner guidewire lumen was noted to be stretched throughout, and the user's sheath distal tip was flared, indicating retraction issues.Therefore, based on the proximal weld break the investigation is confirmed for a break.Additionally, based on the damage to the sheath and the condition to the balloon and guidewire lumen, the investigation is confirmed for retraction issues.The investigation is inconclusive for the reported rupture as the device was unable to be functionally tested.The investigation is confirmed for a dislodged proximal marker band.The marker bands likely dislodged as the inner lumen stretched and as the proximal balloon weld broke distally.It is likely that the balloon weld break resulted in the retraction issues through the sheath.However, the definitive root cause for the identified weld break or reported balloon rupture could not be determined 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.Device code 2923.
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified lesion in the left common iliac vein the pta balloon allegedly ruptured at 10atm during the fourth inflation attempt.The procedure was concluded, and no further treatment was provided.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: 8171466
• Report Number: 2020394-2018-02214
• Device Sequence Number: 16570620
• Product Code: LIT
• UDI-Device Identifier: 00801741060892
• UDI-Public: (01)00801741060892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: ATG80186
• Device Catalogue Number: ATG80186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 92