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

Model Number	ATG80124
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Expiry date (10/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm fistula, the pta balloon allegedly detached from the catheter and impeded blood flow upon removal of the device.It was further reported that a snare device was used to retrieve the detached segment; however, it was unsuccessful.The health care provider (hcp) used a stent to appose the detached segment against the vessel wall.Reportedly, another balloon was used to dilate the stent and the procedure was concluded.The patient was reportedly stable post procedure.
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm fistula, the pta balloon allegedly detached from the catheter and impeded blood flow upon removal of the device.It was further reported that a snare device was used to retrieve the detached segment; however, it was unsuccessful.The health care provider (hcp) used a stent to appose the detached segment against the vessel wall.Reportedly, another balloon was used to dilate the stent and the procedure was concluded.The patient was reportedly stable post procedure.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was returned for evaluation.The sample appeared to be bloody.The balloon was noted to be detached from the device and not returned.Both glue joints were examined and balloon material was noted at each.Stretching and slight kinks were noted to the inner guidewire lumen.The glue bullet was noted to be pulled distally from the distal end of the outer lumen.Both marker bands were noted to be seated together.The stretching, kinking and marker band issue is likely due to the balloon detachment.No functional testing was performed due to the condition of the device.Therefore, the investigation is confirmed for the reported balloon detachment as the balloon has been detached and not returned.The definitive root cause for the reported balloon detachment could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 expiry date (10/2022), g4.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.

• 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: 9970105
• Report Number: 2020394-2020-02902
• Device Sequence Number: 11882985
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: ATG80124
• Device Catalogue Number: ATG80124
• Device Lot Number: 93XD0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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: 57 YR