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

Model Number AB35W06040080

Device Problems Burst Container or Vessel (1074); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used an evercross balloon for distal superficial femoral artery (sfa)/popliteal artery (pa) percutaneous angioplasty procedure.The lesion was described as being heavily calcified.It is reported that the evercross balloon ruptured during inflation and broke off from the shaft as it was being removed through the vascular access sheath.The balloon is reported to have detached completely from its shaft and the inner core.The physician attempted to snare the detached portion "bit" this was unsuccessful initially.This snaring attempt resulted in straddling the puncture site.The physician was successful in pushing the detached portion into the sfa again and it was successfully snared in its entirety.No consequent damage on angiography or clinically, apart from mild groin haematoma.No pseudoaneurysm on uss.The remainder of the stenting procedure was completed without issue.Patient was informed and hospitalised overnight.No long-term injury was reported.

Manufacturer Narrative

Lot a579312 was originally reported.This lot number is not valid.The lot number associated with this event is unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: the evercross was returned.Two non-medtronic 6f sheaths were returned.One sheath showed a snare device loaded the introducer sheath.No other ancillary devices were included.The returned contents were inspected.One non-medtronic 6f sheath had no device loaded.Only the dilator.The second no-medtronic sheath showed a snare device inserted.The snare device had captured the distal end of the fractured catheter shaft and balloon.Approximately 4.5cm of the fractured end was exposed outside of the distal rim of the sheath.The proximal end of the portion of the stent lodged inside the distal rim of the sheath showed the catheter shaft stretched proximally behind the proximal marker band.The stretched catheter shaft indicates a fracture due to exposure to excessive tensile force.The balloon material showed a radial burst.The end of the evercross was pulled out of the sheath in order to inspect the entire segment.The hoop of the snare captured the distal end of the catheter.The length of the segment after pulling from the sheath was approximately 6.5cm.The distal and proximal marker bands were located on the catheter shaft.The proximal segment of the evercross was inspected.The approximate working length was 76cm.The distal end of the catheter showed the proximal bond of the balloon and the radial burst of the balloon.The catheter fracture face was straight.Working length per product labeling is 80 cm and the total length of both returned segments of the evercross was approximately 83.5cm.The longer length is consistent with the observation make of stretching at the fracture location.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: 8099819
• MDR Text Key: 128200447
• Report Number: 2183870-2018-00529
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: AB35W06040080
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A661209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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 Outcome(s): Hospitalization; Required Intervention