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

Model Number H749518080

Device Problems No Display/Image (1183); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2013

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that an image was lost and device was kinked.During a percutaneous coronary intervention (pci), an opticross imaging catheter was used to view the lesion.Lost image occurred.The physician suspected that the image was lost due to the observed kink on the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient status is good.However, returned product analysis revealed a hole in the catheter.

Manufacturer Narrative

Age of time of event: 18 years old or older.Device evaluated by mfr: the complaint device was returned for evaluation.A kink was observed in the sheath assembly from femoral marker at the proximal end.The distance from the distal end of the transducer housing to the tip of the catheter measured.The observed distance was not within specification.The catheter was inserted into a test dispenser coil to orientate the device.During flushing, fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing.The hole was on the outside section of the bond junction.Full image characterization testing cannot be performed based on 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 most probable root cause was unable to be determined.(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: 3702522
• MDR Text Key: 4270111
• Report Number: 2134265-2014-01259
• 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: 02/13/2014

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: 09/11/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16374199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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