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

Model Number	ATG80186
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/ evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2021).
Event or Problem Description
It was originally reported that during an angioplasty procedure, the balloon allegedly ruptured on the second inflation attempt.It was further reported that material from the balloon allegedly detached.The detached material allegedly progressed further into the body and formed a thrombus.The detached material was removed by a snare.There was no further reported complications to the patient.
Event or Problem Description
It was originally reported that during an angioplasty procedure, the balloon allegedly ruptured on the second inflation attempt.It was further reported that material from the balloon allegedly detached.The detached material allegedly progressed further into the body and formed a thrombus.The detached material was removed by a snare.There was no further reported complications to the patient.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be fully detached at the proximal and distal weld locations.The catheter was not returned.Therefore, the investigation is confirmed for a complete balloon detachment.The balloon was able to be filled with water and when pressure was applied, water was noted to be leaking from a rupture in the balloon.Therefore, the investigation is confirmed for a rupture.It is possible that a rupture in the balloon could lead to a balloon detachment during retraction through the sheath.However, based on available information, the definitive root cause for the identified detachment or rupture could not be determined.It is unknown whether procedural issues contributed to the event.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.

• 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: 8544546
• Report Number: 2020394-2019-00515
• Device Sequence Number: 2458631
• Product Code: LIT
• UDI-Device Identifier: 00801741060892
• UDI-Public: (01)00801741060892
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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 Model Number: ATG80186
• Device Catalogue Number: ATG80186
• Device Lot Number: 93SC0178
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: Other