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

Model Number U357564

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 09/16/2021

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.The investigation of the reported event is currently underway.(expiry date: 10/2021).

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly tore off the catheter.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly tore off the catheter during retraction.The procedure was completed by using another device.There was no reported patient injury.

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: one ultraverse 035 pta dilatation catheter loaded within the introducer sheath has been received for the evaluation.On the visual evaluation, the device was noted to be bloody.The distal end of the balloon was noted to be prolapsed over the distal tip while inserted in the introducer sheath.The compound rupture was noted on the balloon and a portion of the balloon was found to be detached.Under the microscopic observation, a kink was noted to the inner guidewire lumen proximal to the introducer sheath.Both the marker bands were present and the distal end marker band found to be moved.No other functional testing was performed.Therefore the investigation for the reported compound balloon rupture was confirmed, as the balloon was ruptured and a portion of the balloon was found to be detached.The investigation for the reported detachment of balloon was also confirmed, since the portion of the balloon got detached on the device returned for the evaluation.The investigation for the identified marker band dislodgement was confirmed, distal end marker band found to be moved within the guide wire lumen.The investigation for the identified difficult to remove was confirmed, as the device was loaded and stuck within the introducer sheath on the returned device.A definitive root cause for the reported compound balloon rupture, detachment of balloon and the identified marker band dislodgement, difficult to remove 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: 10/2021).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.H3 other text : see h10.

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: one ultraverse 035 pta dilatation catheter loaded within the introducer sheath has been received for the evaluation.On the visual evaluation, the device was noted to be bloody.The distal end of the balloon was noted to be prolapsed over the distal tip while inserted in the introducer sheath.The compound rupture was noted on the balloon and the balloon is noted to be still attached.Under the microscopic observation, both the marker bands were present and the distal marker band is noted to be loose and moved from inner guidewire lumen.No other functional testing was performed.Therefore the investigation for the reported compound balloon rupture was confirmed, as the compound rupture was noted on the balloon during the visual evaluation.The investigation for the reported difficult to remove was confirmed, as the device was loaded and stuck within the introducer sheath on the returned device.The investigation for the identified marker band dislodgement was also confirmed, as the distal end marker band found to be loose and moved from inner guidewire lumen.A definitive root cause for the reported compound balloon rupture, difficult to remove and the identified marker band dislodgement 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: 10/2021), g3.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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly tore off the catheter during retraction.It was further reported that balloon was allegedly difficult to be removed.The procedure was completed by using another device.There was no reported patient injury.

• 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: 12792175
• MDR Text Key: 280875384
• Report Number: 2020394-2021-01953
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• 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,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMCY0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG