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

Model Number U3575410

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that during an angioplasty procedure, the catheter was allegedly ruptured.It was further reported that the catheter was stuck in place and distal fragment of the catheter was allegedly detached.Reportedly, the detached fragment was surgically removed and the patient allegedly experienced pain upon removing the ruptured catheter and sedation with anesthesia support was given.The current status of the patient was unknown.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2024).

Event Description

It was reported that during an angioplasty procedure via arteriovenous fistula, the catheter allegedly ruptured.It was further reported that the catheter allegedly got stuck and was difficult to remove.Reportedly, a distal fragment of the catheter detached and wedged at the buttonhole level of the arteriovenous fistula.The detached fragment was surgically removed and the patient experienced pain upon removing the ruptured catheter so sedation with anesthesia support was given.The current status of the patient was unknown.

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: the physical device was not returned for evaluation.Eleven images were reviewed.Review of several fluoroscopic images centered on the arm show an angioplasty attempt possibly through a previously created arterial-venous fistula.In at least three of the images, an object is visualized within the arm that may represent a component of the balloon.The angioplasty balloon is not visualized in these images.An object is visualized within the arm that may resemble a component of an angioplasty balloon, possibly suggesting that this has fractured from the device.Therefore, the investigation is inconclusive for the reported balloon rupture, difficult to remove, entrapment and detachment of device as no objective evidence was obtained from the provided radiographic images.A definitive root cause for the reported balloon rupture, difficult to remove, entrapment and detachment of device 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: 04/2024), g3, h6 (patient, device).H11: section a through f ¿ the information provide by bd represents all 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.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15121391
• MDR Text Key: 296770131
• Report Number: 2020394-2022-00618
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741091988
• UDI-Public: (01)00801741091988
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U3575410
• Device Catalogue Number: U3575410
• Device Lot Number: CMFS0372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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