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

Model Number	0224512
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.(expiry date: 04/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the aortic valve, the pta balloon allegedly got stuck inside the sheath during retraction.It was further reported that medical intervention was required to cut down and remove the balloon from the patient.Reportedly, it is unknown how the angioplasty procedure was completed.The status of the patient is unknown.
Event or Problem Description
It was reported that during an angioplasty procedure in the aortic valve, the pta balloon allegedly got stuck inside the sheath during retraction.It was further reported that medical intervention was required to cut down and remove the balloon from the patient.Reportedly, it is unknown how the angioplasty procedure was completed.The status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the investigation is inconclusive for the reported retraction issue, as the device was not returned for evaluation.The definitive root cause for the reported retraction issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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.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.

• Brand Name: TRUE 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: 9148363
• Report Number: 2020394-2019-03699
• Device Sequence Number: 2656994
• Product Code: OZT
• UDI-Device Identifier: 00801741091001
• UDI-Public: (01)00801741091001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0224512
• Device Catalogue Number: 0224512
• Device Lot Number: GFDR1357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 69