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

Model Number 29710

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported that there was blood-tinged tissue present on the wire.The 100% stenosed target lesion was located in the left superficial femoral artery.A peripheral rotawire guidewire was selected for use.During the procedure, a 2.00mm peripheral rotalink plus system began making a high-pitched noise and the burr seemed to be stuck as the physician attempted to move it slightly back and forth without success.The physician then switched to dynaglide mode to completely remove the burr out of the patient's body and was able to do so.When the rotawire was removed from the patient's body, it was noted that there was blood-tinged tissue present on the wire.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual and microscopic inspection revealed that the device has a kink in the body of the guidewire located approximately at 45 cm from the proximal end.Residue was noted stuck in the body of the guidewire.Therefore, the reported event was confirmed.No other issues were identified during the product analysis.

Event Description

It was reported that there was blood-tinged tissue present on the wire.The 100% stenosed target lesion was located in the left superficial femoral artery.A peripheral rotawire guidewire was selected for use.During the procedure, a 2.00mm peripheral rotalink plus system began making a high-pitched noise and the burr seemed to be stuck as the physician attempted to move it slightly back and forth without success.The physician then switched to dynaglide mode to completely remove the burr out of the patient's body and was able to do so.When the rotawire was removed from the patient's body, it was noted that there was blood-tinged tissue present on the wire.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15121456
• MDR Text Key: 296770746
• Report Number: 2134265-2022-08205
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: 08714729863649
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0029094950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White