MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿ 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749305900180

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as 2134265-2018-02972 and 2134265-2018-02973.It was reported that automatic pullback failure occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified left superficial femoral artery (sfa).An ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and a pullback sled to view the target lesion.During the lower limb percutaneous transluminal angioplasty, the device was used however the shaft got kinked and it became unable to perform pullback.Completed with another with same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a kinks was observed in the telescope assembly from femoral marker to the proximal end, however, the catheter did not present any kinks in the sheath assembly.The telescope assembly was not able to properly pull back, advance, and retract, due to the returned condition of the catheter.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 operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as 2134265-2018-02972 and 2134265-2018-02973.It was reported that automatic pullback failure occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified left superficial femoral artery (sfa).An ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and a pullback sled to view the target lesion.During the lower limb percutaneous transluminal angioplasty, the device was used however the shaft got kinked and it became unable to perform pullback.Completed with another with same device.No patient complications were reported.

• Brand Name: OPTICROSS¿ 18
• 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: 7381534
• MDR Text Key: 104031188
• Report Number: 2134265-2018-02629
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2020
• Device Model Number: H749305900180
• Device Catalogue Number: 30590-018
• Device Lot Number: 21599096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1