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

Model Number 8655

Device Problems Entrapment of Device (1212); Poor Quality Image (1408); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device not return.

Event 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
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7839396
• MDR Text Key: 119032674
• Report Number: 2134265-2018-60663
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR