MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE? AND WIRECLIP? TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 10jul2015.Same case as: mdr id 2134265-2015-05580.It was reported that resistance was encountered when the burr was removed from the rotawire.A 330cm rotawire¿ and 1.25mm rotalink¿ plus were selected and advanced to treat a target lesion located at the left circumflex artery.During withdrawal, resistance was encountered between the burr and the rotawire.The burr and the rotawire were removed together as a unit.The procedure was competed with a different device.No patient complications were reported and the patient's condition was stable.However, device analysis revealed a rotawire detachment.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual inspection was performed and revealed that the device has a kinked distal tip and a wire detachment due to rotational wear (burr issues) in the middle of the device.The overall length could not be measured due to the wire condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: ROTAWIRE? AND WIRECLIP? TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4973644
• MDR Text Key: 6080402
• Report Number: 2134265-2015-05028
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2016
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17292290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2014
• 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