MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB35W04200135

Device Problem Leak/Splash (1354)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use an evercross balloon to treat a lesion in a right leg fem-pop bypass graft (sfa to pt).The device was inspected prior to use and prepped and flushed per the ifu.Negative prep was not performed.It was reported that the balloon was successfully delivered over a non-mdt guidewire to the lesion site.As the physician started to inflate the balloon with a non-mdt inflation device to an unknown pressure, contrast was noticed flowing past the balloon and into the vessel.No balloon expansion occurred.The balloon was then removed from the patient and inflated on the table - again, contrast leaked from the balloon.The physician used a new balloon to complete the procedure without further complication.The patient was treated with a tissue plasminogen activator(tpa) drip overnight.The physician reported that the patient presented with a clot initially.There was never any risk to the patient reported during this procedure.

Manufacturer Narrative

Evaluation summary: the evercross device was received for evaluation.No ancillary devices were included.The evercross was removed and inspected.Traces of clear fluid was noted within the balloon and blood was noted at the distal end of the balloon.No damages to the catheter shaft, manifold, or balloon assembly were observed.The device was front-loaded with a 0.035" guidewire from the lab.An inflation device from the lab was filled with water & was connected to the balloon port of the manifold.At 1 atm a leak was observed at the distal end of the balloon.Upon inspection under microscope the leak originated from a pinhole between the distal end of the balloon and the distal marker band.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7435541
• MDR Text Key: 105634755
• Report Number: 2183870-2018-00230
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684061305
• UDI-Public: 00821684061305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2019
• Device Model Number: AB35W04200135
• Device Lot Number: A325292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 93