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

Model Number H749236310030

Device Problems Break (1069); Separation Problem (4043)

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

Event Date 02/28/2019

Event Type  malfunction  

Event Description

Wire broke and burr separated from shaft of rotalink and sheared off the wire (roto floppy).Device was retrieved with trapping wire with balloon and removing guide, wire, burr, floppy.This issue added time to case; approximately 30 minutes.Product is being retained by hospital for further evaluation.Manufacturer response for roto bur, (brand not provided) (per site reporter).Rep notified; device being retained by hospital for further evaluation.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8499330
• MDR Text Key: 141464862
• Report Number: 8499330
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749236310030
• Device Catalogue Number: H749236310030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA