MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

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

Patient Problems Death (1802); Shock (2072)

Event Date 03/19/2014

Event Type  Death  

Event Description

It was reported that the patient died.The patient presented with a myocardial infarction.One day later the patient underwent an interventional procedure.Vascular access was obtained via the femoral artery.The 99% stenosed, concentric, de-novo, 15mm in length target lesion was located in the severely calcified, 3.0mm in diameter right coronary artery (rca).Pre-dilation was performed with a 3.0 and 2.5 balloon resulting in 95% residual stenosis.A 1.50mm rotalink plus was selected and used for rotablation.The procedure was completed with the implantation of one stent in the rca.Post procedure, it was noted that the patient experienced shock of unknown cause.The patient was administered dopamine and levophed, in addition to a prbc blood transfusion.The patient died one day post procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: ROTALINK? PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3790799
• MDR Text Key: 4435450
• Report Number: 2134265-2014-02382
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2014

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 Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 65