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

Model Number H749518080120

Device Problems No Display/Image (1183); Fracture (1260); Kinked (1339); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device returned has sheath cut and the distal section of the device was not returned.Device analysis revealed no issues or kinks were found in the catheter section received.The functional test cannot be performed due to the returned condition of the catheter.Imaging core windup was not 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 investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 26-feb-2018.It was reported that the sheath was kinked, difficulty removing the catheter from the sheath was encountered and lost image occurred.The 100% stenosed target lesion was located in a moderately tortuous and moderately calcified superficial femoral artery (sfa).An opticross¿ imaging catheter was selected for use.During withdrawal of the catheter after the lesion was observed, it was noted that the sheath of the opticross¿ imaging catheter was kinked when it was tried to remove from the non-bsc introducer sheath.Moreover, resistance was felt when the opticross¿ imaging catheter was removed as it is and lost image occurred.The physician then decided to remove the opticross¿ imaging catheter together with the non-bsc introducer sheath.Another sheath was inserted again and the procedure was completed.No patient injury nor complications were reported.However, device analysis revealed a sheath cut.

Manufacturer Narrative

Describe event or problem and device codes updated.(b)(4).

Event Description

It was further reported that the sheath of the opticross¿ imaging catheter was separated during attempt of removal from the non-bsc introducer sheath.

• 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: 7330344
• MDR Text Key: 102200761
• Report Number: 2134265-2018-02141
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2018
• Device Model Number: H749518080120
• Device Catalogue Number: 51808-012
• Device Lot Number: 21412215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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