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

Catalog Number AB35W04200135

Device Problem Burst Container or Vessel (1074)

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pertains to a nanocross elite device: during aortogram with right leg runoff and subsequent right popliteal artery thromboembolectomy.Disruption of an 0.146 x 200 angioplasty balloon occurred with inability to remove the distal segment which was retained in the severely diseased and essentially previously occluded distal superficial femoral artery and above-knee popliteal artery.Quick cross catheter was advanced into popliteal artery.35 guidewire exchanged out with a 0.14 wire.A 4-200 0.14 evercross balloon was used to further angioplasty the vessel.A balloon burst was reported.An evercross 4x150 was used to complete the procedure.A bolus angiography revealed superficial femoral artery patent, diffusely diseased with irregularities and evidence of focal areas of dissection.A 6x200 nanocross elite balloon was used to angioplasty the popliteal artery above the knee as well as distal superficial femoral artery.No resistance or excessive force was used.It was reported the balloon fractured, the balloon could not be deflated distally.It gradually slated but could not be removed.Further traction on the balloon catheter resulted in separation of the distal two thirds of the balloon catheter.A gooseneck snare was used in an attempt to remove the components without success.The balloon remained in patient, two days post procedure the patient underwent a right popliteal artery endarterectomy to remove retained.No further patient injury reported for this event.

• 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: 8361067
• MDR Text Key: 136848462
• Report Number: 2183870-2019-00086
• Device Sequence Number: 1
• Product Code: LIT
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB35W04200135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2019
• 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 Age: 82 YR
• Patient Weight: 84