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

Model Number U351301210

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 11/06/2021

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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).

Event Description

It was reported that during an angioplasty procedure of stenotic and occluded area in the right iliac-femoral vein, the pta balloon allegedly ruptured at 8 atm.It was further reported that during the retrieval of balloon into the sheath the balloon shaft allegedly broke and had difficulty in retracting the balloon thru the introducer sheath.The procedure was completed using another balloon.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure through stenotic and occluded area in the right iliac-femoral vein, the pta balloon allegedly ruptured at 8 atm.It was further reported that during retrieval of balloon into the sheath, the balloon shaft allegedly broke and had difficulty in retracting the balloon thru the introducer sheath.The balloon was removed from the patient along with the sheath.The procedure was completed using another balloon.There was no reported patient injury.

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: three photos was reviewed.The first picture shows the entire catheter, were the balloon noted to be detached exposing the inner guide wire lumen, the second photo shows the exposed inner guide wire lumen and distal end of the lumen and the third photo shows the detached balloon and the distal tip of the catheter, the balloon appeared to be bloody and compound balloon rupture was noted.No other anomalies were noted on the provided photo.Therefore, based on the photo review, the reported balloon rupture was noted as a compound rupture and also the balloon detachment was able to confirm.However there was no evidence of break and difficult to remove could not be observed and not able to confirm form the provided photos.One ultraverse 035 pta dilatation catheter in two segments was returned for evaluation.On the visual evaluation, segment one the entire catheter and y-body, were the balloon noted to be detached exposing the inner guide wire lumen, the second segment contain the detached balloon and the distal tip of the catheter, the balloon appeared to be bloody and compound balloon rupture was noted, inner guidewire lumen is noted to be twisted.All the anomalies noted on the microscopic observation.No functional testing performed due to the condition of the device.Therefore, the investigation was confirmed for the reported balloon rupture, as a compound balloon rupture was noted on the returned device.The investigation was confirmed for the identified balloon detachment as the device returned in two detached segments for evaluation.The investigation for the reported break remains inconclusive as no specific evidence noted due to the condition of the device returned for evaluation.The investigation was also remains inconclusive for the reported difficult to remove, as the condition of use could not be replicated and no functional testing performed due to the condition of the device.A definitive root cause for the reported balloon rupture, break, difficult to remove and identified 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: b5, d4 (expiry date: 01/2024).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.

• Brand Name: ULTRAVERSE 035 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: 12932112
• MDR Text Key: 281742580
• Report Number: 2020394-2021-02035
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094972
• UDI-Public: (01)00801741094972
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U351301210
• Device Catalogue Number: U351301210
• Device Lot Number: CMFP0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 73 KG