MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB18W040040090

Device Problem Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the powercross dilatation catheter was received for evaluation. The powercross dilatation catheter was received loaded within its protective transportation hoop. No ancillary devices, photographic images, or cine images were received for evaluation. The powercross was received in a post inflation profile, (e. G. Not tightly wrapped or winged), sanguine tinted fluid was observed to be in the balloon chamber. Examination of the proximal balloon bond area of the catheter revealed crimp marks from the manufacture procedure pleat and fold in the area of the balloon chamber proximal bond. These crimps would have restricted the inflation lumen <(>&<)> affected the catheter¿s performance to draw a vacuum to evacuate the balloon chamber. If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a powercross balloon to treat an arteriovenous fistula(avf). The device was prepped as per the ifu with no issues identified. There was no resistance encountered advancing the device and no excessive force was used. No embolic protection was used. The balloon was inflated using a ac3200 inflation device with 50/50 contrast saline solution. The device was reported to have been inflated to a normal atm pressure with no issues. It was reported the physician was unable to deflate the device and used a needle to puncture the balloon through the skin. The balloon was then removed. There was no damage or kinking noted to the device.

• Brand Name: POWERCROSS 018
• 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: 7435614
• MDR Text Key: 105637182
• Report Number: 2183870-2018-00231
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K093286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2018
• Device Catalogue Number: AB18W040040090
• Device Lot Number: A243454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/17/2018 Patient Sequence Number: 1