MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problems Entrapment of Device (1212); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that difficulty in catheter removal occurred.The target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending (lad) artery.During a percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to perform pre intravascular ultrasound (ivus).After a non-bsc guidewire crossed the lesion, an opticross¿ imaging catheter was advanced for visualization.However, after performing auto-pullback from distal to remove the device, resistance was felt.When device was removed with a slight force together with the non bsc guidewire the imaging catheter was found to be torn from the guidewire exit port to the distal side.The procedure was completed with another opticross¿ imaging catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed that a damage on the guidewire exit port assembly.The telescope assembly was not able to properly pull back, advance, and retract, due to the ic windup and broken drive shaft found within the telescope section of the device.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.During image characterization testing, no image appeared in the ilab system.In order to inspect for imaging core (ic) windup at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly was pulled out from hub.Broken drive shaft and ic windup were found within the telescope section of the device.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that difficulty in catheter removal occurred.The target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending (lad) artery.During a percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to perform pre intravascular ultrasound (ivus).After a non-bsc guidewire crossed the lesion, an opticross¿ imaging catheter was advanced for visualization.However, after performing auto-pullback from distal to remove the device, resistance was felt.When device was removed with a slight force together with the non bsc guidewire the imaging catheter was found to be torn from the guidewire exit port to the distal side.The procedure was completed with another opticross¿ imaging catheter.No patient complications were reported.

• Brand Name: OPTICROSS¿
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6257763
• MDR Text Key: 65028674
• Report Number: 2134265-2016-12664
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K123621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2017
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 0019980838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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