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

Model Number H749236310020

Device Problems Entrapment of Device (1212); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) age at the time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as:2134265-2015-09267.It was reported that the sheath was torn and the burr stuck on the wire.Vascular access was obtained via the femoral artery.The 85% stenosed, 24x2.75mm target lesion was located in a mildly tortuous and moderately calcified left anterior descending artery (lad).A 1.25mm rotalink plus and a 330cm rotawire were selected for use.During the procedure, it was noted that the sleeve of the rotalink plus was torn.Subsequently, the burr was not able to get the required speed and the system stalled.Furthermore, the wire was removed along with the burr.The procedure was completed with a different device.No patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for evaluation.Visual examination handshake connection noted no damage.A handshake connection test and a tug test were carried out and no issues were noted as well.The drive shaft coil and sheath were inspected and there was no damage noted.An attempt was made to wet test the unit; however, no speed was met.Advancer unit was dismantled melted ultem was evident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as reason why complaint is identified as user error and the dfu states: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer.¿ (b)(4).

Event Description

Same case as:2134265-2015-09267.It was reported that the sheath was torn and the burr stuck on the wire.Vascular access was obtained via the femoral artery.The 85% stenosed, 24x2.75mm target lesion was located in a mildly tortuous and moderately calcified left anterior descending artery (lad).A 1.25mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, it was noted that the sleeve of the rotalink¿ plus was torn.Subsequently, the burr was not able to get the required speed and the system stalled.Furthermore, the wire was removed along with the burr.The procedure was completed with a different device.No patient complications were reported and the patient's condition was stable.

• 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: 5323790
• MDR Text Key: 34265810
• Report Number: 2134265-2015-09266
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/26/2015

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: 02/29/2016
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016802904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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