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

Model Number U4150415RX

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure of chronic total occlusion in the superficial femoral artery via a contralateral approach, the pta balloon allegedly ruptured at nominal pressure and also the guidewire was bent at the same time.It was further reported that there was resistance felt upon the balloon was retracing and the shaft was found to be torn.Reportedly, the balloon and the guidewire were removed as one unit.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 03/2025).

Event Description

It was reported that during an angioplasty procedure of chronic total occlusion in the superficial femoral artery via a contralateral approach, the pta balloon allegedly ruptured at 6 atm.It was further reported that there was difficulty in retracting the balloon through the introducer sheath and the device and introducer sheath removed as one unit.Reportedly, there was resistance felt upon when the balloon was retracting and the shaft was found to be torn.Reportedly, the balloon and the guidewire were removed as one unit.The procedure was completed using another device.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: one ultraverse rx pta dilatation catheter was received for evaluation.During visual evaluation, the entire length of the catheter was examined for damage revealing a longitudinal tear to the clear portion of the catheter.The guidewire lumen and core-wire were exposed.The inner guidewire lumen had twisting, stretching, and bunching.No rupture was noted to the balloon.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported shaft tear as a longitudinal tear was noted to the clear portion of the catheter.However, the investigation is unconfirmed for the reported balloon rupture as there was no rupture seen on the balloon.Additionally, the investigation is inconclusive for both the reported sheath and guidewire removal difficulty as functional testing could not be performed due to the condition of the sample.A definitive root cause for the reported balloon rupture, sheath removal difficulty, guidewire removal difficulty and shaft tear 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.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.

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 rx pta dilatation catheter was received for evaluation.During visual evaluation, the entire length of the catheter was examined for damage revealing a longitudinal tear to the clear portion of the catheter.The guidewire lumen and core-wire were exposed.The inner guidewire lumen had twisting, stretching, and bunching.No rupture was noted to the balloon.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported shaft tear as a longitudinal tear was noted to the clear portion of the catheter.However, the investigation is inconclusive for the reported balloon rupture as functional testing for the same could not be performed due to the condition of the catheter.Additionally, the investigation is inconclusive for both the reported sheath and guidewire removal difficulty as functional testing could not be performed due to the condition of the sample.A definitive root cause for the reported balloon rupture, sheath removal difficulty, guidewire removal difficulty and shaft tear 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 (expiration date: 03/2025), g3.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 procedure of chronic total occlusion in the superficial femoral artery via a contralateral approach, the pta balloon allegedly ruptured at 6 atm.It was further reported that there was difficulty in retracting the balloon through the introducer sheath and the device and introducer sheath removed as one unit.Reportedly, there was resistance felt upon when the balloon was retracting and the shaft was found to be torn.Reportedly, the balloon and the guidewire were removed as one unit.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX
• 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: 15400397
• MDR Text Key: 302725615
• Report Number: 2020394-2022-00734
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741057618
• UDI-Public: (01)00801741057618
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131199
• 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,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4150415RX
• Device Catalogue Number: U4150415RX
• Device Lot Number: CMGR0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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