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 01/10/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that catheter kinked and lost image occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified distal of right coronary artery.During the percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to view the lesion.It was reported that the opticross¿ was kinked at the connection part of the blue and clear shaft then the image disappeared.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 an open hole at the lap joint area of the catheter.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that no kinks were observed along the length of the catheter.The telescope assembly was able to properly pull back, advance, and retract.The distance from the distal end of the transducer housing to the tip of the catheter measured 25 mm.The observed distance is not within specification.Fluid was leaking from an open hole at the lap joint area when the catheter was flushed.The imaging window is still connected to the blue sheath at the lap joint.Device was inserted into test dispenser coil.Leak is located on the outside edge of the device.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.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: 3822510
• MDR Text Key: 4399212
• Report Number: 2134265-2014-02709
• 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: 04/23/2014

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: 11/07/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16519860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• 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