MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE FLOW DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number	TF0223512
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 a tavr procedure the outer fiber shell of the balloon allegedly began to partially peel off during retraction through the sheath.The balloon was able to be successfully retracted 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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the outer fiber-based jacket to have been completely inverted and detached from the balloons.The jacket was returned over the catheter shaft.Additionally, the outer parylene coating on the balloons was found to be peeling throughout the length of each balloon.Therefore, the investigation is confirmed for a detached outer jacket, and for peeled parylene.However, the investigation is inconclusive for the alleged unintended movement as the conditions of use could not be recreated.It is likely that the detachment of the outer jacket contributed to the identified peeled parylene.However, the definitive root cause for the identified detachment of the outer jacket or reported unintended balloon movement 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.
Event or Problem Description
It was reported that during a tavr procedure the outer fiber shell of the balloon allegedly began to partially peel off during retraction through the sheath.The balloon was able to be successfully retracted through the sheath.Another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7409963
• Report Number: 2020394-2018-00360
• Device Sequence Number: 11014654
• Product Code: OZT
• UDI-Device Identifier: 00801741097669
• UDI-Public: (01)00801741097669
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152613
• 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): 06/01/2018

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: 09/28/2019
• Device Catalogue Number: TF0223512
• Device Lot Number: GFBW2849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 84