MAUDE Adverse Event Report: PLYMOUTH ATK TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number THS-LS-C

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 08/25/2014

Event Type  Injury  

Event Description

This procedure was performed in (b)(6).The procedure was endovascular therapy of the right sfa stenosis with atherectomy.The turbohawk was deployed via the left femoral into the target area.The atherectomy device was able to pass up to 6 times, (1st insertion 3 passes, 2nd insertion 3 passes), but on the third pass of the second insertion, the subject experienced a perforation.The physician performed balloon angioplasty (2atm, 360 seconds) to the perforation site.

Manufacturer Narrative

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

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.

• Brand Name: ATK TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN PLYMOUTH; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4110372
• MDR Text Key: 4758380
• Report Number: 2183870-2014-00239
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2017
• Device Model Number: THS-LS-C
• Device Catalogue Number: THS-LS-C
• Device Lot Number: 9851218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• Is the Device Single Use?: Yes
• 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: 68 YR
• Patient Weight: 55