MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned with a non- boston scientific wire.A visual inspection of the returned device revealed a kink in the proximal sheath assembly.There was no damage observed on the distal tip, however, the guidewire exit port assembly was found damaged(deformed/lifted).Microscopic inspection revealed the guidewire exit port was damaged (deformed/lifted).The telescope assembly was able to properly pull back, advance, and retract.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.
Event or Problem Description
It was reported that device entanglement occurred.The target lesions were located in the severely calcified mid left anterior descending (lad) artery and diagonal.An opticross 6 hd imaging catheter was advanced over a long non boston scientific (bsc) wire into the mid lad.A short non bsc wire was in the side branch diagonal.When the physician tried to remove the opticross catheter it got hung up on the side branch wire and both the wire and catheter had to be removed together.The opticross catheter was advanced into the lad over the long wire once again and upon removal the catheter got stuck on this wire and both devices had to be removed together.There was no harm to the patient but due to the severity of the calcification, the next day the patient was transferred to another hospital for a rotapro procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned with a non- boston scientific wire.A visual inspection of the returned device revealed a kink in the proximal sheath assembly.There was no damage observed on the distal tip, however, the guidewire exit port assembly was found damaged(deformed/lifted).Microscopic inspection revealed the guidewire exit port was damaged (deformed/lifted).The telescope assembly was able to properly pull back, advance, and retract.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.
Event or Problem Description
It was reported that device entanglement occurred.The target lesions were located in the severely calcified mid left anterior descending (lad) artery and diagonal.An opticross 6 hd imaging catheter was advanced over a long non boston scientific (bsc) wire into the mid lad.A short non bsc wire was in the side branch diagonal.When the physician tried to remove the opticross catheter it got hung up on the side branch wire and both the wire and catheter had to be removed together.The opticross catheter was advanced into the lad over the long wire once again and upon removal the catheter got stuck on this wire and both devices had to be removed together.There was no harm to the patient but due to the severity of the calcification, the next day the patient was transferred to another hospital for a rotapro procedure.The device was returned with a non- boston scientific wire.A visual inspection of the returned device revealed a kink in the proximal sheath assembly.There was no damage observed on the distal tip, however, the guidewire exit port assembly was found damaged(deformed/lifted).Microscopic inspection revealed the guidewire exit port was damaged (deformed/lifted).The telescope assembly was able to properly pull back, advance, and retract.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.

• Brand Name: OPTICROSS 6
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11490399
• Report Number: 2134265-2021-03377
• Device Sequence Number: 14449200
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 11/19/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0026392744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1