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

Model Number AB18W060200150

Device Problem Burst Container or Vessel (1074)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 04/23/2015

Event Type  Injury  

Event Description

The patient presented with a severely calcified left sfa with a chronic total occlusion (cto).The cto was crossed with a wire and glide catheter.The physician was going to pta the heavily calcified area with a powercross 6x200.During inflation at 8atm the balloon burst.While withdrawing the powercross, the balloon detached from the catheter.This was noted when the catheter came out without the balloon.Under fluoro the balloon could be seen partially inside the sheath with about 80mm still outside of it.The retrieval of the powercross balloon was not possible so the spiderfx was withdrawn attempting to capture the tip of the balloon.The tip of the balloon was captured and the two systems, along with the sheath, were being withdrawn when extra force was required, causing the spider wire to break.At this point, the only viable solution was to perform a cut down.A full femoral cut down was performed and an arteriotomy made in the femoral artery allowed complete extraction of the remains of the ruptured balloon and the spider basket.Please reference mdr 2183870-2015-00190 for the spiderfx used in this procedure.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Event Description

Evaluation summary: the powercross catheter exhibited a circumferential tear at the proximal cone.The inner shaft was fractured within the outer sheath and was not visible in the remaining balloon chamber material.The balloon material did not exhibit any longitudinal tearing at the tear site.Part of the powercross inner shaft was necked-down on the capture wire core.

• Brand Name: POWERCROSS
• Type of Device: TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4787919
• MDR Text Key: 18093532
• Report Number: 2183870-2015-00189
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: AB18W060200150
• Device Catalogue Number: AB18W060200150
• Device Lot Number: A028984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 110