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

Catalog Number CE1812050120OTW

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Cine analysis: the cine images were received.The images are of the targeted vessel anatomy in the right proximal popliteal artery.Images 1 and 3 appear to be duplicates of each other, above the knee, and both contain what appears to be a support sheath at the top of the image.Image 2 is at the knee and shows a tight stenosis of the artery.The chocolate device cannot be seen in any of the images.Device analysis: the chocolate device was received for evaluation.No ancillary devices were received for analysis.The chocolate device was received with the balloon chamber in a post-inflation profile.The distal end of the balloon chamber was examined and the chocolate nitinol cage remained firmly attached.The proximal end of the balloon chamber was examined and the chocolate nitinol cage remained firmly attached to the catheter.A 0.018¿ guidewire was loaded through the distal tip of the catheter and navigated out the guidewire port with ease.A 10cc water filled syringe was attached to the inflation port of the y-manifold and a vacuum was pulled.The vacuum could be maintained.A 20cc water filled syringe with manometer was attached to the inflation port and the syringe was inflated to a pressure of 12-atm, but the balloon would not inflate.The pressure was left on for over 20-minutes.The inflation lumen is most likely obstructed with solidified contrast from the procedure.The distal end of the returned device was compared to the distal end of another chocolate device that was not involved with this procedure.The distal nitinol wires are standing proud of the distal balloon bond on the returned device but the nitinol wires remain bonded to the chocolate device.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was intending to use a chocolate balloon to treat a 20mm moderately calcified lesion with 90% stenosis in the right proximal popliteal artery.Artery diameter was 5mm with no tortuosity.A 6fr non medtronic sheath and an non medtronic 0.018 guidewire was used in the procedure.No embolic protection was used.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped per ifu with no issues.The device did not pass through a previously deployed stent.No resistance was encountered during advancement and excessive force was not used.The device was inflated with a non medtronic inflation device using visipaque 320 inflation fluid.Dilation was successfully completed using the device and balloon was deflated.It was reported that the physician encountered difficulty removing the balloon while pulling back the catheter.The physician felt that the chocolate was somehow jamming when he wanted to pull it back.He eventually managed and he noticed that the nitinol wire had become loose and protruded at the distal end of the catheter.No patient injury was reported.

• Brand Name: CHOCOLATE
• 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: 8574578
• MDR Text Key: 144554297
• Report Number: 2183870-2019-00208
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CE1812050120OTW
• Device Lot Number: F180424501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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 Age: 81 YR
• Patient Weight: 70