MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) OPTICROSS?; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problems No Display/Image (1183); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2013

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that severe resistance and image lost were encountered.The opticross¿ imaging catheter was used to visualize a lesion it was noted that during percutaneous coronary intervention, severe resistance was encountered when imaging core was got back to the initial position and image was lost.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.However, returned device analysis revealed an open hole in the sheath lap joint assembly.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was received with a kink observed in the sheath assembly at 72.5 cm from femoral marker at the distal end.An open hole was observed in the sheath lap joint assembly 72.5 cm from the femoral marker at the distal.Fluid was leaking from an open hole in the lap joint assembly when the catheter was flushed.The telescope assembly was not able to properly pullback or advance.No wind up was observed on the imaging core during x-ray analysis.The ccp board pins appeared normal and a good click sound was heard during insertion into the mdu system.Full image characterization testing cannot be performed based on the returned condition of the catheter, however during impedance testing good image was observed.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

• Brand Name: OPTICROSS?
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3835825
• MDR Text Key: 21879999
• Report Number: 2134265-2014-02941
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16501431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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