MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U41502H30

Device Problems Peeled/Delaminated (1454); Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.Expiration date: (expiry date: 04/2022).

Event Description

It was reported that during preparation for an angioplasty procedure, the pta balloon was allegedly damaged.It was further reported that another balloon was used to complete the procedure.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultraverse 014 device was received for evaluation.The balloon protector and stylet were noted to be received with the device.A kink was noted to the catheter shaft.Under microscopic evaluations it appeared the outer balloon material was peeling off the balloon.No other anomalies were noted to the balloon.4 electronic photos were also provided for review.Photo 1 shows the device labeling matching the reported information.Photos 2-4 show the device in the inner packaging hoop, with the distal end of the balloon protector and stylet sticking out of the hoop.The stylet can be noted to be pulled distally away from the end of the balloon protector.No damage to the device can be noted.Therefore, the investigation is confirmed for the reported damaged device as a kink was noted to the device.The investigation is also confirmed for the identified peeling as the outer balloon material appears to be peeling off.The definitive root cause for the damaged device and peeling material could not be determined based upon the evaluation 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: 04/2022), g3, h6 (method).H11: b5, h6 (device, 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 prior to an angioplasty procedure, the pta balloon was allegedly damaged.It was further reported that another balloon was used to complete the procedure.There was no patient contact.

• Brand Name: ULTRAVERSE 014 PTA DILATATION CATHETER
• 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: 12587765
• MDR Text Key: 275151033
• Report Number: 2020394-2021-01837
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064449
• UDI-Public: (01)00801741064449
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U41502H30
• Device Catalogue Number: U41502H30
• Device Lot Number: CMDS0464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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