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

Catalog Number RV80615

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that the pta balloon allegedly ruptured at 12atm in the sfa.It was further reported that during retraction through the sheath, a balloon segment allegedly sheared off and detached in the sfa.Reportedly, medical intervention was required to place a stent and appose the balloon segment against the vessel wall.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection: the sample was returned used.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 6mm x 15cm balloon.A segment of the balloon and inner catheter was detached and not returned for evaluation.Stretching and bunching of the inner catheter was noted at the distal end of the detachment point, indicating that excessive force had most likely been applied to the catheter during retraction.The balloon detachment occurred 68.5cm from the strain relief.It is unknown whether the balloon ruptured longitudinally or circumferentially, as the tear at the location of the balloon detachment was both longitudinal and circumferential.The proximal marker band was present on the catheter, but the distal marker band was not returned for evaluation.Functional/performance evaluation: functional testing could not be performed due to the condition in which the sample was received.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: based upon the conditions in which the device was returned, the investigation is confirmed for retraction issues, a balloon rupture, a balloon detachment, and a marker band detachment.Per the reported event details, the balloon was used to treat a hard calcification.It is possible that the calcified lesion contributed to the balloon rupture.However, the definitive root cause for the balloon rupture could not be determined based upon available information.It is likely that the balloon rupture contributed to the inability to retract the balloon from the sheath and the balloon detachment.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current rival pta dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The information provided by bard 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 bard.

Event Description

It was reported that the pta balloon allegedly ruptured at 10atm in the sfa.It was further reported that during retraction through the sheath, a balloon segment allegedly sheared off and detached in the sfa.Reportedly, medical intervention was required to place a stent and appose the balloon segment against the vessel wall.Five days post event, it was further reported that the artery was allegedly occluded by the balloon segment which led to surgical intervention (implantation of a bypass graft).Patient status is unknown.

• Brand Name: RIVAL PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5329337
• MDR Text Key: 34451694
• Report Number: 2020394-2015-02062
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: RV80615
• Device Lot Number: GFZB2957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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
• Patient Age: 59 YR
• Patient Weight: 70