MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number U3575106

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2022

Event Type  Injury  

Event Description

It was reported that during an angioplasty in a left upper arm fistulagram, the balloon allegedly ruptured.It was further reported that mid balloon shaft was allegedly broken and distal half of the balloon was still in patient.Reportedly veinotomy with additional access site was used to retrieve the balloon segments.The procedure was completed using another balloon.Patient reported as stable.

Manufacturer Narrative

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.However, photos and images were provided for review.The investigation of the reported event is currently underway.

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.Three photos were provided and reviewed.The first photo shows the balloon which ruptured circumferentially, and the distal end of the balloon and catheter noted to detached.The second and third photos shows two different balloons, were one balloon in good shape in deflated position and another one noted to have circumferential rupture and detached balloon.Therefore, based on the submitted photos, the reported balloon rupture and balloon detachment can be confirmed.Two images were reviewed.An x-ray of the left upper extremity in an obese patient is reviewed.There appears to be a remnant of a catheter and possibly an angioplasty balloon.As per the reported issue a least part of the device remained retained within the patient.This is confirmed by the images provided, therefore, based on the submitted images, the reported balloon rupture and balloon detachment could be confirmed on the findings.Based on the submitted photos and images, the investigation was confirmed for the reported balloon rupture and balloon detachment as the balloon noted to have circumferential rupture and distal end of catheter and balloon was detached.A definitive root cause for the reported balloon rupture and balloon 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.H10: d4 (expiry date: 05/2023), g3, h6 (method).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 an angioplasty in a left upper arm fistulogram, the balloon allegedly ruptured and the mid balloon shaft was allegedly broken.It was further reported that the distal half of the balloon was still in patient and venotomy with additional access was used to retrieve the balloon segments.Patient reported as stable.

• Brand Name: ULTRAVERSE 035
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13892688
• MDR Text Key: 287850297
• Report Number: 2020394-2022-00217
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094590
• UDI-Public: (01)00801741094590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U3575106
• Device Catalogue Number: U3575106
• Device Lot Number: CMET0437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG