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

Catalog Number UNK ULTRAVERSE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with history of atherosclerosis of right lower extremity with rest pain was scheduled for intervention.The left common femoral artery was accessed and a co2 angiogram was performed which demonstrated the superficial femoral artery was occluded distally with reconstitution of tp trunk and at distally.A 4x150 pta balloon was used to cross the popliteal occlusion and was inflated.Follow up angiogram demonstrated a short dissection.The decision was made to place a stent secondary to the dissection.A 5x100 stent was used to cross the popliteal artery and was post-dilated.Follow-up angiogram demonstrated resolution of occlusion with antegrade flow.The sheath was removed and good hemostasis was noted.

Event Description

It was reported through the results of a clinical trial that an angioplasty balloon crossed a popliteal occlusion and was inflated.Follow up angiogram demonstrated a short dissection and the decision was made to place a stent.The current patient status was not provided.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was not returned and images were not provided.However, medical records were provided.A 4x150 ultraverse pta device was used to cross the popliteal occlusion and inflated to 10 mmhg.The follow up angiogram demonstrated patency of the distal sfa, popliteal with short dissection in retrogeniculate popliteal artery with patent flow to infrageniculate popliteal artery, at and tp trunk.Based on the medical records, dissection of the vessel can be confirmed.However, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the reported device.The definitive root cause could not be determined based upon the available information labeling review: the review of the ifus (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported through the results of a clinical trial that an angioplasty balloon crossed a popliteal occlusion and was inflated.Follow up angiogram demonstrated a short dissection and the decision was made to place a stent.The current patient status was not provided.

• Brand Name: ULTRAVERSE PTA BALLOON DILATATION 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: 8203572
• MDR Text Key: 131662297
• Report Number: 2020394-2018-02258
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ULTRAVERSE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention