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); Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-08486.It was reported that the rotawire was stuck in the lesion and with the rotaburr and the patient experienced vasospasm.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified proximal to middle left anterior descending artery (lad).A 330cm rotawire¿ and 2.0mm rotalink¿ plus were selected for use.Ablation was performed three times with the rotaburr; however while on dynaglide to withdraw the rotawire, the distal end of this device was stuck on peripheral blood because of spasm.It was further observed under fluoroscopy that the tip of the rotawire was stretched.Also, resistance was encountered between the burr and wire.The devices had to be removed together as a whole.A coronary dilating agent was administered and a micro catheter was inserted to successfully remove the burr and wire.The rotawire was checked outside the patient's body and about 2mm of the coil from the tip was stretched at about 10cm.The procedure was completed with this device.There were no further patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the device was kinked and the distal tip was stretched.Also, the core wire was broken at 328cm from the proximal end and the other section of the core wire was attached to the ball weld.The overall length and the outer diameter (od) could not be performed due to the device condition.The od of middle and proximal section of the device are within specification.A device history record (dhr) review was performed and no deviation was found.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 mdr id: 2134265-2017-08486.It was reported that the rotawire was stuck in the lesion and with the rotaburr and the patient experienced vasospasm.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified proximal to middle left anterior descending artery (lad).A 330cm rotawire¿ and 2.0mm rotalink¿ plus were selected for use.Ablation was performed three times with the rotaburr; however while on dynaglide to withdraw the rotawire, the distal end of this device was stuck on peripheral blood because of spasm.It was further observed under fluoroscopy that the tip of the rotawire was stretched.Also, resistance was encountered between the burr and wire.The devices had to be removed together as a whole.A coronary dilating agent was administered and a micro catheter was inserted to successfully remove the burr and wire.The rotawire was checked outside the patient's body and about 2mm of the coil from the tip was stretched at about 10cm.The procedure was completed with this device.There were no further patient complications reported.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6787616
• MDR Text Key: 82460594
• Report Number: 2134265-2017-07719
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20190429(10)0020583785
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0020583785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2017
• 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: GUIDE CATHETER, 7F EBU3.5
• Patient Outcome(s): Required Intervention