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

Model Number H802228240022

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at the time of event: (b)(6) or older.(b)(4).Device evaluated by manufacturer: the device was returned for evaluation.Examination of the returned device noted that the guide wire is broken at 327.8cm approximately from the proximal side.The coil tip was not returned.There was no evidence of wear reduction at the broken point.Several kinks were also noted along the guide wire.All the measured outer diameters 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).

Event Description

Same case as mdr id: 2134265-2015-05036.Reportable based on device analysis completed on 26aug2015.It was reported that a guidewire kink occurred.The moderately tortuous and severely calcified, diffused target lesion was located in the left anterior descending (lad) artery.During the procedure, the target lesion was dilated using a 1.5mm flextome balloon catheter.Following dilatation, an unspecified intravenous ultrasound (ivus) catheter was delivered; however, it was unable to cross the lesion.Subsequently, a 1.75 mm rotalink plus was selected for treatment.However, when the physician delivered the device, the burr got stuck near the left main trunk (lmt) and was unable to move.The guide catheter was then advanced and the whole system was removed as a single unit from the patient's body.The procedure was completed with a 1.25mm and a 1.5mm rotalink burr.No patient complications were reported and the patient's status is good.It was further reported that the wire was kinked.However, device analysis revealed of a fractured guidewire.

• 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: 5098760
• MDR Text Key: 26601859
• Report Number: 2134265-2015-06284
• 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: company representative,distri
• Reporter Occupation: Physician
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17696513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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