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

Catalog Number	AB18W040040090
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7435614
• Report Number: 2183870-2018-00231
• Device Sequence Number: 1677878
• Product Code: LIT
• UDI-Device Identifier: 00821684046272
• UDI-Public: 00821684046272
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K093286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention