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

Model Number H749236310050

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a rotalink overheating occurred.A 2.00mm rotalink plus was selected for use.At the end of the first examination, while milling an artery, the guide rotalink presented an unusual overheating.No patient complications were reported.

Manufacturer Narrative

Device lot number corrected from 19150629 to 0017471298.Batch expiration date corrected from 31-mar-2018 to 31-oct-2016.Batch manufactured date corrected from 25-apr-2016 to 25-nov-2014.Device evaluated by mfr: the device was returned for analysis.Microscopic and visual inspection were performed on the sheath, coil , burr, annulus and handshake connections.The sheath was separated 29cm ¿ 35cm from the distal of the sheath.The separated ends appeared to be jagged and damaged, which indicates that the separation was due to tensile overload.Functional test was performed by connecting the rotablator rotalink plus device to a rotablator control console system.There was water leaking from the separation in the sheath and the device was not able to get any speed.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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

It was reported that a rotalink overheating occurred.A 2.00mm rotalink¿ plus was selected for use.At the end of the first examination, while milling an artery, the guide rotalink presented an unusual overheating.No patient complications were reported.

• 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: 5830866
• MDR Text Key: 50722421
• Report Number: 2134265-2016-07097
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

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: 10/31/2016
• Device Model Number: H749236310050
• Device Catalogue Number: 23631-005
• Device Lot Number: 0017471298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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