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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
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.
Event or Problem Description
It was reported that during an angioplasty procedure in the left external iliac vein, the pta balloon allegedly ruptured at 6atm during the third inflation attempt.It was further reported that balloon got stuck inside the sheath during retraction.Upon removing the balloon and sheath together as one unit, a partial segment of the balloon catheter allegedly detached but was successfully removed from the patient.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 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 balloon material was noted to be prolapsed over the distal tip.Additionally, the user's introducer sheath tip was noted to be flared and damaged, indicating retraction issues.Therefore, based on the proximal weld break the investigation is confirmed for a break.The investigation is unconfirmed for the reported detachment.It is likely the user perceived the break as a detachment.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.It is possible that a balloon rupture could lead to retraction issues through the sheath and subsequent balloon weld break.However, the definitive root cause for the reported or identified issues 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.H10: g4.H11: g5, h3, h6 (results 1, conclusion 1) (trending device code: removed 2907) h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure in the left external iliac vein, the pta balloon allegedly ruptured at 6atm during the third inflation attempt.It was further reported that balloon got stuck inside the sheath during retraction.Upon removing the balloon and sheath together as one unit, a partial segment of the balloon catheter allegedly detached but was successfully removed from the patient.Another balloon was used to 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: 8047853
• Report Number: 2020394-2018-01990
• Device Sequence Number: 16595902
• 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: K181323
• 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): 05/01/2019

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 Expiration Date: 06/28/2021
• Device Model Number: ATG80186
• Device Catalogue Number: ATG80186
• Device Lot Number: 93TC0139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 87