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

Model Number	TF0223512
Medical Device Problem Codes	Difficult to Insert (1316); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a balloon aortic valvuloplasty, the balloon allegedly had difficulty being inserted through the sheath.Another device was used to perform the procedure.There was no patient contact.
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 proximal portion of the outer jacket to be peeling toward the distal tip.The device was functional tested by advancing the catheter and guide wire through an in-house sheath, which passed without issue.However, slight resistance was noted during retraction, caused by the peeled outer jacket.This observation will be considered incidental because the device was damaged prior to functional testing, and retraction issues would be expected.Therefore, the investigation is confirmed for the peeling outer jacket, but unconfirmed for the reported difficult to insert issue.The definitive root cause for the identified peeled outer jacket could not be determined based upon 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.H10: d4 ( expiry date: 11/2019), 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.
Event or Problem Description
It was reported that during a balloon aortic valvuloplasty, the balloon allegedly had difficulty being inserted through the sheath.Another device was used to perform the procedure.There was no patient contact.

• Brand Name: TRUE FLOW PTV DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8249445
• Report Number: 2020394-2018-02320
• Device Sequence Number: 2190387
• Product Code: OZT
• UDI-Device Identifier: 00801741097669
• UDI-Public: (01)00801741097669
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K172932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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 Model Number: TF0223512
• Device Catalogue Number: TF0223512
• Device Lot Number: GFBY2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR