MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ROTALINK¿ BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number H802227680020

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

Patient Problems Death (1802); Occlusion (1984)

Event Date 03/31/2017

Event Type  Death  

Manufacturer Narrative

Age at time of event: mid 50's.Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-04138.It was reported that there was no blood flow in the entire left side of the heart and the patient expired.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending (lad)artery.A 1.25mm rotalink¿ burr and rotawire¿ were selected for use.During the procedure, rotablation was performed in the target lesion.After the third or fourth run, it was noticed that there was no blood flow in the entire left side of the heart.Eventually, the heart stopped.Balloon pump, cardiopulmonary resuscitation, breathing assistance and pharmacological assistance were performed in response to the event.However, the heart was not recovered and the patient expired.

• Brand Name: ROTALINK¿ BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6519135
• MDR Text Key: 73611432
• Report Number: 2134265-2017-03902
• 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
• Type of Report: Initial
• Report Date: 04/04/2017

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: H802227680020
• Device Catalogue Number: 22768-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/25/2017
• 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