MAUDE Adverse Event Report: COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number CB1413540040OTW

Device Problems Use of Device Problem (1670); Device Damaged by Another Device (2915); Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a chocolate pta balloon with a 6fr 45cm non-medtronic sheath and non-medtronic 0. 014 guidewire during treatment of  the patient's mid and distal right popliteal artery and tibial/popliteal trunk. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. There were no issues noted when removing the device from the hoop/tray. The device was prepped as per ifu without issue. A non-medtronic inflation device was used with contrast saline for balloon inflation. The device was passed through a previously deployed stent. No resistance was noted during advancement.  after the balloon was deflated and was being removed, the nitinol cage of this chocolate balloon accidentally interacted with distal part of newly implant non-medtronic self-expanding (se) stent, which was implanted in same procedure and proximal to the balloon. The chocolate balloon was not used as post dilation. The distal part of stent was damaged a little and migrated proximally, according to the physician. The nitinol cage of the balloon was damaged and very little portion detached in the vessel. The chocolate balloon was removed successfully and the stent implanted was post dilated with a non-medtronic balloon. It is not sure if there was vessel injury, but flow was patent. No further injury reported.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13190156
• MDR Text Key: 291381183
• Report Number: 2183870-2022-00012
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CB1413540040OTW
• Device Lot Number: B4481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial