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

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Poor Quality Image (1408); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not return.
Event or Problem Description
It was reported that catheter removal difficulty occurred.The target lesion was located in a severely tortuous circumfex artery.A synergy stent was implanted.An opticross imaging catheter was selected for use.During procedure, after one intravascular ultrasound (ivus) run was performed, a second run was attempted but was not able to acquire an image.The shaft of the catheter began to shake.Ivus was stopped and then the catheter was very difficult to remove from the patient's body.The opticross imaging catheter was able to be removed intact.However, the transducer would not advance or retract within the sheath after removal.Examination was performed under fluoroscopy and detached tip of a non-bsc guidewire was observed in the artery.It was seen under fluoroscopy that the tip of the non-bsc guidewire became entrapped within the implanted synergy stent.No damage was noted on the synergy stent.The patient was stable; however, the patient went to surgery for retrieval of the detached tip.No further patient complications were reported.

• Brand Name: OPTICROSS
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7839396
• Report Number: 2134265-2018-60663
• Device Sequence Number: 13905372
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 09/11/2018
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0021114416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1
• Patient Age: 40 YR