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

Model Number H749236310030

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id 2134265-2015-09161.It was reported that a rotawire fracture issue occurred.A 1.50mm rotalink¿ plus and a 325cm rotawire were selected for treatment.During preparation, outside the patient's body, the rotation speed was increased to 200,000rpm; however, it was noted that the rotawire was torn.The procedure was completed with another of the same rotawire.There were no patient complications reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for evaluation.The burr unit & the advancer unit were returned to site connected together.The device was returned with a rotawire running through the device which was removed from the device without issue.Visual examination and tug test was conducted which observed no issues.The burr was microscopically examined and observed that the annulus was damaged/blocked.No issues were noted with the exposed brass on the plated back half of the burr.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Same case as mdr id 2134265-2015-09161.It was reported that a rotawire fracture issue occurred.A 1.50mm rotalink¿ plus and a 325cm rotawire were selected for treatment.During preparation, outside the patient's body, the rotation speed was increased to 200,000rpm; however, it was noted that the rotawire was torn.The procedure was completed with another of the same rotawire.There were no patient complications reported and the patient's condition was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5324479
• MDR Text Key: 34998447
• Report Number: 2134265-2015-09159
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0017986269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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