MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The opticross imaging catheter was introduced for ultrasound examination of the target lesion.The catheter got bent at the hemostasis valve location.The motor drive continued to spin and would not shut off.When the physician tried to remove the catheter from the guidewire, there was tremendous resistance.The catheter and guidewire had to be removed together and upon removal it was apparent that the catheter had wrapped the wire around itself.There were no patient complications.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed kinks in the sheath assembly and the imaging window and tip entangled with a guidewire.Microscopic inspection revealed no damage to the distal tip or guidewire exit port assembly.Pitting and degradation of the transducer housing consistent with saline damage was observed which occurs post-use of the device and is not related to the original device failure.
Event or Problem Description
It was reported that device entrapment occurred.The opticross imaging catheter was introduced for ultrasound examination of the target lesion.The catheter got bent at the hemostasis valve location.The motor drive continued to spin and would not shut off.When the physician tried to remove the catheter from the guidewire, there was tremendous resistance.The catheter and guidewire had to be removed together and upon removal it was apparent that the catheter had wrapped the wire around itself.There were no patient complications.It was further reported that this was the same event reported in mdr 2134265-2022-05343.The 70% stenosed, tight target lesion was located in the mild to moderately calcified and mildly tortuous mid left anterior descending artery.The opticross imaging catheter was advanced to size the lesion prior to stent implantation.After a synergy stent was implanted, the same opticross was advanced over a 185cm non-boston scientific wire to assess the deployed stent.When the physician turned the image on, he felt the catheter rotate in his fingers outside the hemostasis valve.The physician tried to turn the image off but it would not so the physician quickly pulled the entire wire and catheter out of the patient.The rotating catheter was wrapped around the guidewire inside the patient making removal from the wire impossible.The entire catheter, from the distal tip and toward the proximal end was wrapped with the guidewire.There were no patient complications and angiography did not reveal any damage to the artery.The procedure was completed using an alternate method or device.
Event or Problem Description
It was reported that device entrapment occurred.The opticross imaging catheter was introduced for ultrasound examination of the target lesion.The catheter got bent at the hemostasis valve location.The motor drive continued to spin and would not shut off.When the physician tried to remove the catheter from the guidewire, there was tremendous resistance.The catheter and guidewire had to be removed together and upon removal it was apparent that the catheter had wrapped the wire around itself.There were no patient complications.It was further reported that this was the same event reported in mdr 2134265-2022-05343.The 70% stenosed, tight target lesion was located in the mild to moderately calcified and mildly tortuous mid left anterior descending artery.The opticross imaging catheter was advanced to size the lesion prior to stent implantation.After a synergy stent was implanted, the same opticross was advanced over a 185cm non-boston scientific wire to assess the deployed stent.When the physician turned the image on, he felt the catheter rotate in his fingers outside the hemostasis valve.The physician tried to turn the image off but it would not so the physician quickly pulled the entire wire and catheter out of the patient.The rotating catheter was wrapped around the guidewire inside the patient making removal from the wire impossible.The entire catheter, from the distal tip and toward the proximal end was wrapped with the guidewire.There were no patient complications and angiography did not reveal any damage to the artery.The procedure was completed using an alternate method or device.

• Brand Name: OPTICROSS
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14246294
• Report Number: 2134265-2022-04972
• Device Sequence Number: 4887303
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0028676658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 06/10/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown