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

Model Number	AT75166
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
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 right common iliac vein, the pta balloon allegedly ruptured at 10atm on the third inflation attempt.Reportedly, there was moderate difficulty retracting the balloon through the sheath.Another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the right common iliac vein, the pta balloon allegedly ruptured at 10atm on the third inflation attempt.Reportedly, there was moderate difficulty retracting the balloon through the sheath.Another balloon was used to complete the procedure.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.Investigation summary: the device was returned for evaluation.An inflation attempt was made and water was seen exiting the balloon.The fibers were stripped from the device and a pinhole rupture was noted.Therefore, the investigation is confirmed for pinhole rupture.However, the investigation is inconclusive for the reported retraction issue as the device was unable to be fully functionally tested due to the rupture, and as the original sheath used the procedure was not returned.It is possible that the identified rupture contributed to the reported retraction issue.However, the definitive root cause for the reported or identified issues could not be determined based upon the available information.It is unknown if the original sheath used in the procedure contributed to the reported retraction issue.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 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: 7930363
• Report Number: 2020394-2018-01839
• Device Sequence Number: 16623002
• Product Code: LIT
• UDI-Device Identifier: 00801741062476
• UDI-Public: (01)00801741062476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• 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): 01/03/2019

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: 03/28/2021
• Device Model Number: AT75166
• Device Catalogue Number: AT75166
• Device Lot Number: GFCQ3292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 68