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

Model Number CB1415025120OTW

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/26/2022

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 during treatment of a calcified lesion in the patient's proximal posterior tibial artery.  moderate vessel tortuosity and calcification are reported. Lesion exhibited 60% stenosis. 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. The device was not passed through a previously deployed stent. No resistance was encountered during advancement. It is reported a break/fracture occurred on the tip of the device during advancement through the guide catheter. The detached tip was removed with the catheter. The procedure was completed with a different brand device. No 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14249592
• MDR Text Key: 290543422
• Report Number: 2183870-2022-00164
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/29/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CB1415025120OTW
• Device Catalogue Number: CB1415025120OTW
• Device Lot Number: B3270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial