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

Model Number H802228240022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Pulmonary Edema (2020); Tachycardia (2095)

Event Date 09/17/2015

Event Type  Death  

Manufacturer Narrative

Udi: ((b)(4).Device evaluated by mfr: the device was not received for analysis.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 2134265-2015-06976 and 2134265-2015-06978.It was reported that the patient died.Vascular access was obtained via the femoral artery.The 90% stenosed, 35x3.2mm, concentric, de novo target lesion was located in the mildly tortuous and mild to moderately calcified ostial to proximal left anterior descending (lad) artery.A 1.50mm rotalink plus and 330cm rotawire were used for treatment.The speed was set at 160,000rpms and ablations were done three times at 40 seconds duration.There were no restrictions encountered and the wire had no fracture or bending issues.Post-dilatation was then performed using a 2.75 nc balloon catheter.However, immediately after post-dilatation, the patient experienced tachycardia resulting in pulmonary edema.A 3.00x38mm promus element long drug-eluting stent was then advanced and implanted.The patient was also treated with intra-aortic balloon pump (iabp) and cardiac massaging; however, patient's condition did not improve.Subsequently, the patient went into cardiac arrest and died.

• 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: 5152740
• MDR Text Key: 28363529
• Report Number: 2134265-2015-06977
• 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,distri
• Reporter Occupation: Physician
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17642470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 58 YR