MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problems Entrapment of Device (1212); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as 2134265-2016-04302.It was reported that a burr became stuck on the rotawire.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal, mid and distal right coronary artery.A 1.50mm rotalink¿ plus and 330cm rotawire¿ were selected for use.During the procedure, after a successful ablation with a 1.25mm burr, the physician exchanged the burr to a 1.50mm burr.While in dynaglide mode, the physician attempted to remove the burr outside the patient's body; however, strong resistance was noted.It was also observed that the rotawire was kinked.The physician then pulled both devices from the patient's body together and attempted to separate the burr from the rotawire outside the patient's body; however, the rotawire could not be removed from the burr.Subsequently, ivus and predilatation were performed and a synergy stent was deployed.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned loaded in the rotalink catheter.The rotalink catheter has kinks in the middle of the catheter.Visual inspection of the rotawire identified a kink near the proximal section, in addition the guidewire has the spring tip kinked and stretched.The guidewire could not be removed from the rotalink catheter due to the kink at the proximal end of the device by the handshake connection and the kinks in the middle of the device.A dimensional inspection found that the outer diameter of the middle and proximal sections of the wire were within specification.The distal section could not be measured due to the spring tip being kinked and stretched.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

Same case as 2134265-2016-04302.It was reported that a burr became stuck on the rotawire.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal, mid and distal right coronary artery.A 1.50mm rotalink¿ plus and 330cm rotawire¿ were selected for use.During the procedure, after a successful ablation with a 1.25mm burr, the physician exchanged the burr to a 1.50mm burr.While in dynaglide mode, the physician attempted to remove the burr outside the patient's body; however, strong resistance was noted.It was also observed that the rotawire was kinked.The physician then pulled both devices from the patient's body together and attempted to separate the burr from the rotawire outside the patient's body; however, the rotawire could not be removed from the burr.Subsequently, ivus and predilatation were performed and a synergy stent was deployed.No patient complications were reported and the patient's status was good.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5656409
• MDR Text Key: 45222209
• Report Number: 2134265-2016-04301
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 17617343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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
• Treatment: GUIDING CATHETER: HEART RAIL AL75 SH/ JR4 SH