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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS PTA4.0MM X 210MM X 170CM TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER

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COVIDIEN RAPIDCROSS PTA4.0MM X 210MM X 170CM TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER Back to Search Results
Model Number A14BX040210170
Device Problems Wire; Material Rupture; Sticking
Event Date 12/11/2014
Event Type  Malfunction  
Event Description

The rapidcross became stuck on the wire and ruptured. The physician had to remove the balloon and wire together. Investigation of the returned device on (b)(6), 2014, found the rapidcross pta rapid exchange balloon dilatation catheter was received in two sections: proximal section with inflation hub, and a distal section with the balloon chamber.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

(b)(4). 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 rapidcross pta rapid exchange balloon dilatation catheter was received for evaluation with a guidewire locked up in the guidewire lumen of the device. The rapidcross pta rapid exchange balloon dilatation catheter was received in two sections: proximal section with inflation hub, and a distal section with the balloon chamber. The two sections are separated at the proximal rx port of the catheter. The catheter separation appears to be tensile separation with a section of the catheter being necked down and or stretched due to tensile forces. The distal section was examined and the guidewire appears to be locked up in the guidewire lumen. Push and pull forces were applied to the guidewire in an attempt to advance the guidewire in either direction to no avail. A flushing tool was attached to the proximal end of the distal section and the balloon chamber was inflated: no leaks or tears were noted in the balloon chamber material. The guidewire lumen within the balloon chamber is stretched to the point that the two middle marker bands are within 15mm, from the distal tip of the device. The device underwent destructive testing to locate the point of guidewire lockup. The guidewire in the proximal section could be freely removed. The guidewire in the remaining distal section could not be moved in either direction. The remaining distal section, was cut at its midpoint. The guidewire in the proximal section could be freely removed.

 
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Brand NameRAPIDCROSS PTA4.0MM X 210MM 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  
MDR Report Key4404633
Report Number2183870-2015-00008
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 12/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/03/2016
Device MODEL NumberA14BX040210170
Device Catalogue NumberA14BX040210170
Device LOT Number9943161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/06/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2014
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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