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

Catalog Number CB1812050120OTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the chocolate pta balloon catheter device was returned to medtronic investigation lab for evaluation.The device was received coiled inside two biohazard bags.No ancillary devices were received for evaluation.The device returned with an unknown material stuck on the catheter shaft at the distal end.Biologics are present along the device and inside the balloon.Visual inspection of the unknown material under a microscope is possibly coating material from an accessory device used with the chocolate device.The material can move/slide along the catheter shaft and feels like coating.Both marker bands are visible and intact and there is no damage noted to the balloon, chocolate cage or the distal tip.It was not possible to flush the device or load a 0.018¿ guidewire due to lots of biologics within the device.The device was connected to the pressure gauge and the balloon was inflated to nominal pressure (6atm) and rated burst pressure (12atm) with no difficulty.The balloon held pressure and deflated with no issues.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a chocolate pta balloon along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a severely calcified lesion in the left mid to distal superficial femoral artery (sfa) and popliteal artery (pop).The vessel was mildly tortuous.The vessel diameter and lesion length are 5mm and 200mm respectively.No embolic protection was used.The balloon was inflated with a syringe.There was no issue when taking the product out of the tray.The device was prepped per ifu with no issues identified.The device did not pass through a previously deployed stent.There was resistance encountered when advancing the device.It was reported that when the balloon was removed, something like the coating on the outermost layer of the shaft peeled off.There was no detached portion of device remained in the patient.When this product was removed to some extent, it was completely removed together with the guiding to prevent scattered pieces from being left in the patient's body.The catheter/delivery system deformed at the shaft.Physician was of the opinion that there was a possibility that the shaft part of the device contacted calcification during delivery and removal so the coating was peeled off or since the non-medtronic guide catheter was smaller in diameter than recommended there was a possibility that the shaft part was scraped by contacting the tip of the guide when it was removed.Alt hough recoil occurred, it cannot be determined whether it was due to the effect of peeling.The device did not detach at the shaft, balloon or cage region.No "peeling" remained in the patient body.No intervention was required for the removal of the device.The treatment for the recoil was to dilate the lesion using a non-medtronic (shiden hp 4-100) device after removing the chocolate balloon.It was noted that dissection occurred.The procedure was completed with a non-medtronic (ranger) balloon and the patient was discharged from the hospital.No further patient 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12545672
• MDR Text Key: 273736254
• Report Number: 2183870-2021-00357
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: CB1812050120OTW
• Device Lot Number: B4921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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): Required Intervention