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

Model Number U357588

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Embolism (1829)

Event Date 07/27/2020

Event Type  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.(expiry date: 01/2023).

Event Description

It was reported that performed a post-dilatation procedure, the pta balloon allegedly ruptured.The hcp withdrew the device with difficulty, elongation of the shaft and missed distal part of the pta they noticed a circumferential rupture that make the way out very difficult, part of the balloon while performing a thrombo-embolectomy.This part could have migrated lower in the leg, causing embolism and ischemia.The patient was hospitalized.

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: one ultraverse 035 pta device was returned for evaluation.A visual inspection was performed and the device was detached into three segments, the catheter was detached and partial balloon was attached to it.Distal tip of the balloon was noted to be ruptured circumferentially and inner guidewire lumen was also noted to be detached separately from the device.Functional testing could not be performed due to the condition of device.Therefore, the investigation is confirmed for the reported circumferential rupture and detachment issue.The definitive root cause for the reported material rupture and detachment issue could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 01/2023),g4.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 through a post-dilatation procedure, the pta balloon allegedly ruptured.The hcp withdrew the device with difficulty, elongation of the shaft and distal part of the pta was missed.Reportedly a circumferential rupture was noticed that makes the way out very difficult, so a part of the balloon was grasped while performing a thrombo-embolectomy.Otherwise, this part could have migrated lower in the leg, causing embolism and ischemia.The patient was hospitalized.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10412789
• MDR Text Key: 203091834
• Report Number: 2020394-2020-05391
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093975
• UDI-Public: (01)00801741093975
• Combination Product (y/n): N
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357588
• Device Catalogue Number: U357588
• Device Lot Number: CMEP0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other