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

Catalog Number AB35W10040080

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received: physician employed the use of an evercross pta balloon catheter with a 7fr non-mdt sheath and non-mdt inflation device for the treatment of a native heavily calcified pseudoaneurysm in the common iliac artery. Access was from both sides retrograde, intervention was made from the right side. Vessel diameter reported as being 9mm. This balloon was passed through a previously deployed stent. Balloon was inflated to a pressure of 12 atm's once. Physician experienced difficulties when attempting to deflate the balloon as it would not deflate. Physician then observed that blood was going back into the inflation device when it was under vacuum, but the device was not inflating. Physician then made another puncture in the patients treated vessel close to the introducer. Physician had to puncture the balloon to release pressure, so it could be removed from the patient. It was reported no pieces of balloon were left in the patient. Patient is reported as being fine. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cines were received contained six dicom image folders. Five of the folders contain single images of the abdominal aortic and common iliacs from different times in the procedure. The sixth folder contains exam protocol spread sheet. Cine image 1 shows measurement of the targeted common iliac artery. A guidewire and support sheath can be identified in the cine image. Cine image 2 shows an expanded view of the targeted common iliac artery. A guidewire can be identified in the cine image. Cine image 3 shows two stents have been implanted in the common iliac arteries. The stent in the patient¿s right common iliac artery is identified as being 14mm in diameter and 40mm in length. The stent in the patient¿s left common iliac artery is identified as being 12mm in diameter and 60mm in length. A guidewire is identified running through the right common iliac artery and into the abdominal aorta. A support sheath is identified running through the left common iliac artery and into the abdominal aorta. Cine image 4 shows the same anatomy as cine image 3 but with an injection of contrast flowing through the vessels. Cine image 5 shows a broader image of cine image 4 and the contrast flow. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

An evercross pta balloon was used for an angioplasty procedure. It was reported a balloon burst occurred. It was not possible to retract the deflated balloon through the sheath. Due to this issue, the physician had to puncture the balloon subcutaneously. After removal of the sheath, the user observed that the main part of the balloon was detached from the wire.

• 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: 7116280
• MDR Text Key: 100545698
• Report Number: 2183870-2017-00574
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/22/2020
• Device Catalogue Number: AB35W10040080
• Device Lot Number: A480956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/14/2017 Patient Sequence Number: 1