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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS PTA2.0MM X 150MM X 170CM TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER

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COVIDIEN RAPIDCROSS PTA2.0MM X 150MM X 170CM TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER Back to Search Results
Model Number A14BX020150170
Device Problems Balloon; Wire; Coiled; Material Separation
Event Date 11/17/2014
Event Type  Injury  
Event Description

The patient was scheduled for angiogram of the left forearm and left hand. The radial artery was wired down to the wrist and the balloon was advanced and the lesions were ballooned. The balloon was inflated to 10atm for 1 inflation. Upon removal of the balloon the balloon catheter the balloon separated in half. This occurred close to the pelvic area and it was noted that the. 014 wire was coiled in the aorta. At that time a snare was introduced and the rest of the balloon was removed with the wire.

 
Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event. Additional information has been requested. Should it become available a supplemental report will be submitted.

 
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.

 
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Brand NameRAPIDCROSS PTA2.0MM X 150MM X 170CM
Type of DeviceTRANSLUMINAL 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 Key4338551
Report Number2183870-2014-00321
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/18/2016
Device MODEL NumberA14BX020150170
Device Catalogue NumberA14BX020150170
Device LOT Number9776015
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2013
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: 12/17/2014 Patient Sequence Number: 1
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