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

Model Number H802228240022

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at the time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was returned for analysis.Visual inspection observed a kink in the middle of the device in several sections and of the distal end.Also, the distal tip was noted to be detached.The overall length was not measured due to the device condition.The od of he middle of the device and proximal section were within specification.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).

Event Description

Reportable based on device analysis completed on 17aug2015.It was reported that the wire was kinked and resistance was encountered during advancement.Vascular access was obtained via the femoral artery.The totally occluded, 16x2.75 mm target lesion was located in the severely tortuous and calcified mid left anterior descending artery (lad).A 330 cm rotawire¿ was selected to advance to the target lesion.Upon introduction, while advancing the rota burr along the rotawire, resistance was encountered.The physician was unable to load the rota burr into the guidewire.The guidewire was then removed and a kink was noted on the device.The procedure was completed using another of the same device and the same rota burr.No patient complications were reported and the patient's status is stable.However, device analysis revealed of a detached/separated distal tip.

• 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: 5077495
• MDR Text Key: 25804863
• Report Number: 2134265-2015-06121
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17651442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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