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

Catalog Number	ATG120182
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information regarding this balloon rupture, we are taking a conservative approach and will report this event as a complicated balloon rupture.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, the pta balloon allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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.Upon further investigation of the returned device, a pinhole rupture was noted on the proximal cone of the balloon.Therefore, the investigation is confirmed for a pinhole rupture.However, there was no information that reported a potential retraction issue, detachment of balloon material, nor vessel damage; therefore, this event will be reported as a malfunction mdr as a complicated balloon rupture.Conclusion: the device was returned for evaluation.An inflation attempt was made and a pinhole rupture was noted on the proximal cone of the balloon.Therefore, the investigation is confirmed for a pinhole rupture.The definitive root cause for the identified rupture could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.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: 7131007
• Report Number: 2020394-2017-01774
• Device Sequence Number: 2144476
• Product Code: LIT
• UDI-Device Identifier: 00801741060861
• UDI-Public: (01)00801741060861
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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 Expiration Date: 12/31/2018
• Device Catalogue Number: ATG120182
• Device Lot Number: 93KZ0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1