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

Catalog Number	ATG80142
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2018
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 subclavian vein, the pta balloon was unable to be retracted through the sheath after the second inflation/deflation attempt.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the subclavian vein, the pta balloon was unable to be retracted through the sheath after the second inflation/deflation attempt.The procedure was concluded, and no further treatment was provided.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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned inserted through the user's introducer sheath for evaluation.A visual inspection device found a complete break to the proximal weld joint of the balloon.Additionally, the sheath tip was noted to be flared.Therefore, the investigation is confirmed for a complete break of the proximal balloon joint, as well as for sheath-related retraction issues.Based on the condition of the returned sample condition, it is likely that resistance was encountered by the user leading to breakage of the proximal weld joint as the device was being withdrawn through the sheath.However, the definitive root cause for the identified retraction 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.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.

• 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: 7515747
• Report Number: 2020394-2018-00673
• Device Sequence Number: 1438910
• Product Code: LIT
• UDI-Device Identifier: 00801741060731
• UDI-Public: (01)00801741060731
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: ATG80142
• Device Lot Number: 93NC0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 90