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

Catalog Number UNKNOWN TRUE

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Vascular Dissection (3160)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported during the angioplasty procedure, the pta balloon was allegedly ruptured and it did sheer off and they were able to snare the part that remained.It was further reported that patient had a small tear in vessel upon removal.The current status of the patient is unknown.

Event Description

It was reported during the procedure, the valvuloplasty balloon was allegedly ruptured and it did sheer off and they were able to snare the part that remained.It was further reported that patient had a small tear in vessel upon removal.The patient current status is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the 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.H3 other text : device not returned.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11927847
• MDR Text Key: 254035433
• Report Number: 2020394-2021-01158
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• PMA/PMN Number: K150667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN TRUE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other