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

Catalog Number	AB35W05040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used an evercross balloon during treatment of the patient¿s left subclavian vein.Ifu was followed and the device was prepped without issue.Non-medtronic wires 5fr 10 cm sheath and inflation device were used.It is reported that the balloon ruptured following first inflation.The balloon was inflated to rated burst pressure (rbp).When the burst occurred, the balloon broke off the catheter and was unable to be removed from the patient.Excessive force was used when trying to withdraw the balloon.It is believed that the balloon remained attached to the catheter following the burst until it reached a more proximal stenosis in which excessive force was used in attempt to cross this lesion.It appears that this proximal lesion is where the balloon came apart from the catheter.Patient was taken to surgery to remove the balloon.No attempts at snaring the balloon were made.
Additional Manufacturer Narrative
Additional information: the balloon did not go through a stent.The lesion was described at 'soft plaque'.Evaluation summary: the evercross dilatation catheter was received for evaluation.The components of the evercross dilatation catheter along with an introducer sheath were received.The proximal balloon chamber cone remained attached to the outer sheath and the balloon chamber inner guidewire lumen was received separated from the dilatation catheter.The balloon chamber inner guidewire lumen appeared stretched but still contained its two radiopaque marker bands.Separately to the components listed above, the evercross distal tip was received still bonded to the distal segment of the balloon chamber material.The balloon chamber material appeared to be accordion folded/bunched up with a radial separation face.A second segment of the balloon chamber material was also found.The second segment exhibited both radial and longitudinal tearing.All components of the evercross dilatation catheter were accounted for.Four photographic images of cine images were received for evaluation.The first two cine images are of the targeted vessel anatomy ¿ the subclavian vein.The images show two areas of tight lesions - one near the shoulder and the other about mid shaft of humerus bone.The third image is of the evercross inflated at the targeted lesion.Based on the guidewire in the image it appears that the physician was using a radial approach to treat the lesion.The fourth image is of the ruptured balloon about mid shaft of humerus bone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8096072
• Report Number: 2183870-2018-00519
• Device Sequence Number: 16863854
• Product Code: LIT
• UDI-Device Identifier: 00821684061381
• UDI-Public: 00821684061381
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2021
• Device Catalogue Number: AB35W05040080
• Device Lot Number: A707542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/10/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR