MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that a wire separation occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery.A 330cm rotawire and wireclip torquer was selected for use.During the procedure, it was noted that the rotawire got separated approximately 6cm from the tip inside the patient's body.The device was retrieved by using a snare.The procedure was completed with a different device.There were no complications reported.

Event Description

It was reported that a wire separation occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery.A 330cm rotawire and wireclip torquer was selected for use.During the procedure, it was noted that the rotawire got separated approximately 6cm from the tip inside the patient's body.The device was retrieved by using a snare.The procedure was completed with a different device.There were no complications reported.It was further reported that there were no fragments left inside the patient's body.A 2.00mm rotablator was used.The wire appeared to have a bend on the detached portion once removed.The patient's condition was good post procedure.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

E1: initial reporter address: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The customer sent four images of the device and its damages; the photos were attached to the complaint.The guidewire returned together with its original opened pouch.The guidewire was found broken/fractured; the damaged section was located approximately at 319.8 cm from the proximal end.The distal section of the guidewire returned inside of a petri dish; the distal tip was kinked and stretched.No more damages were found in the device.Dimensional inspection of the outer diameter (od) of distal tip, od of middle of the device and od of proximal section of the device were performed and were within specification.Dimensional inspection of the overall length could not be performed due to the device condition.

Event Description

It was reported that a wire separation occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery.A 330cm rotawire and wireclip torquer was selected for use.During the procedure, it was noted that the rotawire got separated approximately 6cm from the tip inside the patient's body.The device was retrieved by using a snare.The procedure was completed with a different device.There were no complications reported.It was further reported that there were no fragments left inside the patient's body.A 2.00mm rotablator was used.The wire appeared to have a bend on the detached portion once removed.The patient's condition was good post procedure.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9490988
• MDR Text Key: 171896402
• Report Number: 2134265-2019-15949
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

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: 07/02/2021
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0024053759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 01/20/2020
• Supplement Dates FDA Received: 01/02/2020; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Patient Outcome(s): Required Intervention