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

Model Number VA8094

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

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 device has been returned to the manufacturer for evaluation as well as a photo was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly ruptured.It was further reported that the tip and bottom portion of the balloon broke off into the patient.The broken piece was retrieved from patient through surgical intervention.The current patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was returned for evaluation.One photo was reviewed.The photo shows that the scissor was holding the ruptured balloon which is noted to have the compound rupture and the distal end of the balloon noted to be detached from the catheter.Balloon was noted to be bloody and no other anomalies were noted.Therefore, based on the photo review, the reported balloon detachment and the compound balloon rupture can be confirmed.One vaccess pta dilatation catheter has been received in two segments for the evaluation.On the visual evaluation, the first segment consists of the catheter loaded onto an unknown sheath which exposes the inner guidewire lumen and a small portion of the detached balloon attached to the catheter.On further the marker bands were located on the guidewire lumen.The second segment consists of the detached balloon portion and the compound rupture was noted to the balloon.No other specific anomalies were noted.On the functional evaluation, the catheter was removed from unknown sheath successfully and the distal tip of the sheath was noted to be buckled.Therefore the investigation for the reported detachment of balloon was confirmed, as the balloon was returned in two segments for the evaluation.The investigation for the reported balloon rupture was confirmed, as compound rupture was noted on the balloon and the balloon got detached into two segments on the device returned for the evaluation.The investigation for the identified difficult to remove was confirmed, as the catheter returned loaded onto an unknown sheath for the evaluation.A definitive root cause for the reported balloon rupture, detachment of balloon and the identified difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, g3, h6 (device, method).H11: h6 (patient, result, conclusion).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 : see h10.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly ruptured at 2 atm and the tip and bottom portion of the balloon broke off into the patient.It was further reported that the broken piece was retrieved from patient through surgical intervention.The current patient status was unknown.

• Brand Name: VACCESS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12624102
• MDR Text Key: 276168900
• Report Number: 2020394-2021-01864
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741121357
• UDI-Public: (01)00801741121357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VA8094
• Device Catalogue Number: VA8094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention