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 03/16/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 28apr2015.It was reported that a guide wire kink occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending coronary artery.A 330cm rotawire was used for advancement.During procedure, it was noted that the wire was kinked.The procedure was completed with another of the same device.There were no complications reported and the patient's status was good.However, device analysis revealed a broken distal tip.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was returned for evaluation.Visual inspection of the device observed that the distal tip was broken at 327.8cm approximately from the proximal end; also, the spring tip was not returned.Moreover, the body was kinked at 114.5cm approximately.From the proximal end.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: 4795272
• MDR Text Key: 5853222
• Report Number: 2134265-2015-03015
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2016
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17274337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2014
• 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