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

Model Number H802232390012

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2015.It was reported that a wire kink occurred.The circumferential target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A rotawire¿ and wireclip¿ torquer was used for advancing.The rotawire was delivered through an unspecified microcatheter, then the rotablator was also delivered.However, resistance was encountered upon delivery of the rotablator.The wire was then suspected to be kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed body fracture.

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed and observed that the body was fractured at 328.1cm approximately from the proximal end.Moreover, the distal end including the spring tip approximately 1.9cm was not returned.All the outer diameter measurements are within the specifications.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: 4848077
• MDR Text Key: 5932282
• Report Number: 2134265-2015-03663
• 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: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2016
• Device Model Number: H802232390012
• Device Catalogue Number: 23239-001
• Device Lot Number: 17528086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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