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

Model Number H749518080

Device Problems Fluid/Blood Leak (1250); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2014.It was reported that kinked and leakage occured.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified left anterior descending (lad) artery.During the percutaneous coronary intervention (pci) outside the patient, an opticross imaging catheter was used to view the lesion.It was noted that the connection area of the opticross got kinked.During flushing, leakage occured at that kinked connection part.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed a hole at the sheath lap joint area of the catheter.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that the no kink or leak was found in the telescope section of this catheter.A kink was observed in the imaging window assembly at 67.1 cm from femoral marker at the distal end.Open hole at the sheath lap joint assembly.Fluid was found leaking from an open hole at the lap joint area when the catheter was flushed.The imaging window was still connected to the blue sheath tubing at the lap joint.The telescope assembly was not able to properly pull back, advance, or retract.Since the telescope cannot advance the transducer distal housing (tdh) to the most distal position, the distance from the distal end of the transducer housing to the tip of the catheter was not measured.During image characterization testing in the roller coaster model, a good square image appeared in the system.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: 3869891
• MDR Text Key: 20783805
• Report Number: 2134265-2014-03291
• 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: 05/16/2014

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: 11/12/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16529386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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