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

Model Number	0244512
Medical Device Problem Codes	Failure to Fold (1255); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the true dilatation balloon valvuloplasty products that are cleared in the us.The product classification code for the true dilatation balloon valvuloplasty product is identified.The lot number for the two malfunctions were provided and a lot history review was performed.The devices have been returned for evaluation; the evaluation unconfirmed fail to fold and retraction issue.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes 2 malfunctions.A review of the reported information indicated that model 244512 true balloon valvuloplasty catheter allegedly experienced failure to fold and a retraction problem.This information was received from various sources.The two malfunctions involved two patients with no patient consequences.The age, weight, and genders of the two patients were not provided.

• Brand Name: TRUE 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: 9572523
• Report Number: 2020394-2020-00185
• Device Sequence Number: 327969
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: No Information
• Device Model Number: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFDQ1630, GFDR0526
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1