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

Model Number H749518080

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that the telescope was unable to get back to its initial position.The opticross¿ imaging catheter was used for a percutaneous coronary intervention.During the procedure, it was noted that the telescope was not able to get back to its initial position.The procedure was completed with another of the same device.No patient complications were reported and the patients' condition is good.However, returned device analysis revealed an open hole at the lap joint area.

Manufacturer Narrative

(b)(4).The complaint device was returned for evaluation.A kink was observed in the sheath assembly at 72.5 cm from femoral marker at the distal end.The telescope assembly was not able to properly pull back, advance, or retract.No damages were found on the ccp board pins.A good click sound was heard during insertion into the mdu system.An open hole was observed at the sheath lap joint section of the device.Fluid was leaking from the open hole at the sheath lap joint assembly when the catheter was flushed.Impedance testing finds that there was no electrical disconnect in the imaging circuit.Full image characterization testing cannot be performed based on the returned condition of the catheter.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.The imaging core (drive shaft) was found broken off at the hub shaft connector.Windup of the imaging core was also 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).

• 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: 3966314
• MDR Text Key: 4751075
• Report Number: 2134265-2014-04412
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16267101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2013
• 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