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

Model Number 0204511

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that during a valvuloplasty procedure, the pta balloon allegedly ruptured.It was further reported that the balloon allegedly detached and the fragments were left in the juxta renal aortic position.The patient current status was unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.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 for the reported balloon rupture and detachment 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.(expiry date: 10/2023).

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one true pta dilatation catheter was received for evaluation.During visual evaluation, the balloon was noted to be detached from the proximal joint.It was not returned.The guide-wire lumen was found not exiting the outer catheter.The outer catheter was shaved and the guide-wire lumen was seen.The edge of the guide-wire lumen was noted to be detached.The distal segment was not returned.No kinks noted to the catheter shaft and no anomalies noted to the luers/y-body.Functional testing could not be performed due to the condition of the sample.Two photos were provided and reviewed.The first photo shows the detached balloon of the true pta dilatation catheter.It appears bloody.The second photo shows the detached balloon of the true pta dilatation catheter.It appears bloody.Therefore, based on the submitted photos, balloon detachment can be confirmed.The investigation is confirmed for the reported balloon and inner guidewire lumen detachment since the balloon was noted to be detached from the proximal joint during photo review and visual evaluation, and the edge of the guide-wire lumen was noted to be detached during visual evaluation.Therefore, the investigation is inconclusive for the reported balloon rupture since no evidence for the balloon rupture was seen.The investigation is inconclusive for the reported difficult to remove since functional testing could not be performed.A definitive root cause for the reported balloon rupture, balloon and inner guidewire lumen detachment and 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, d4 (expiry date: 10/2023), g3, h6 (device).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.

Event Description

It was reported that during a valvuloplasty procedure in aortic valve via large bore access through right femoral artery, the pta balloon allegedly ruptured at third inflation attempt.It was further reported that the balloon allegedly got detached and the fragments were left in the juxta renal aortic position.Reportedly, the balloon was allegedly difficult to remove.The patient current status was reported as stable.

• Brand Name: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12889096
• MDR Text Key: 281391432
• Report Number: 2020394-2021-02013
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741090998
• UDI-Public: (01)00801741090998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150667
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0204511
• Device Catalogue Number: 0204511
• Device Lot Number: GFEX0644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG