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

Model Number H802232390012

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem Vasoconstriction (2126)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Reportable based on product analysis completed on (b)(4) 2014.It was reported that difficulty crossing lesion and bent distal tip occurred.The 99% stenosed, 40mm in length target lesion was located in the severely tortuous and severely calcified 2.5mm in diameter left anterior descending artery.A rotawire and wireclip torquer was selected and advanced to the target lesion but was unable to cross.After several attempts the distal tip of the device was bent prior to inserting the rotaburr.It was noted that a possible vasospasm occurred and the rotawire was trapped in the vessel, so the core wire was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed a corewire fracture.

Manufacturer Narrative

Age at time of event: 18 years and older.Device evaluated by mfr: the device was returned for analysis.The visual and tactile examination of the returned device revealed spring tip severely damage.The coilwire unraveled and the corewire fractured.All the outer diameter measurements are within the specifications.(b)(4) lab revealed that failure occurred due to reverse/rotational bending overload.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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3869735
• MDR Text Key: 19590431
• Report Number: 2134265-2014-03123
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2015
• Device Model Number: H802232390012
• Device Catalogue Number: 23239-001
• Device Lot Number: 0016612371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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): Other