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

Model Number H802223301

Device Problem Fracture (1260)

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 09/30/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id#2134265-2015-07216.It was reported that wire tip fracture, vessel perforation and patient death occurred.The chronic total occlusion target lesion was located in the heavily calcified (360 degrees worth) ostial/proximal right coronary artery (rca).A rotawire elite guide wire crossed via an antegrade approach.During advancement of a 1.50mm rotalink plus burr at , the wire fractured and the burr perforated the vessel.The burr speed was 190-200k rpm at the time of the event.The burr and part of the wire was removed; however, 20-30cm of the distal wire was left inside the patient.A non-bsc covered stent was deployed to seal the vessel perforation.4 days later, the patient died.

• Brand Name: ROTAWIRE ELITE¿ 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: 5184724
• MDR Text Key: 29733177
• Report Number: 2134265-2015-07215
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2017
• Device Model Number: H802223301
• Device Catalogue Number: 22330
• Device Lot Number: 18282032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 91098167FA
• Patient Sequence Number: 1
• Patient Outcome(s): Death