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

Catalog Number CB1413540120OTW

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

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 45cm sheath and guidewire during procedure to treat a mildly calcified fibrous lesion in the right mid superficial femoral artery (sfa). The vessel diameter and lesion length were 4mm and 100mm respectively. An indeflator was used for balloon inflation. Mixture of contrast and physiological saline was used as inflation fluid. The product did not have any malfunction when it was taken out of the package. The device was prepped per ifu with no issues noted. It was reported that during balloon inflation, it was difficult to inflate the balloon at 9atm. Balloon deflation difficulty also occurred. The device would not deflate at the lesion site. Deflation issue was noted during subsequent inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. When at the lesion site the balloon was first inflated to 9atm with the chocolate balloon 4-120mm, inflation failure was confirmed in the center of the balloon. Physician removed the balloon from the body, tested for inflation, and tried again to inflate at the lesion site after confirming that the balloon was firmly inflated. The balloon inflated to 8atm at the lesion site, and deflation was attempted, but failed to deflate even after 30 minutes. The distal part of the superficial femoral artery was pierced with a puncture needle from the body surface, and the chocolate balloon with poor deflation was broken and retrieved. Patient injury was reported with hemorrhage/bleed at access site.

• 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: 12411669
• MDR Text Key: 274909535
• Report Number: 2183870-2021-00312
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 0704582777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CB1413540120OTW
• Device Lot Number: B4057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2020
• 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: 09/01/2021 Patient Sequence Number: 1