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

Model Number H749518080

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that during a percutaneous coronary intervention (pci); shaft kink, catheter leak and resistance when moving the telescope back to its initial position occurred.The target lesion was located in the 90% stenosed, moderately tortuous and mildly calcified left anterior descending artery.An opticross¿ imaging catheter was inserted to observe the vessel during the pre intravascular ultrasonography (ivus) then pre-dilatation was performed using unspecified balloon catheter and the unspecified stent was implanted.After which, flushing was performed prior to post-ivus however, it was noted that saline leaked from the catheter.Furthermore, when the device was checked, the connecting area of the distal shaft was found to be kinked.Moreover, the physician felt resistance when moving the telescope back to its initial position after pre-ivus.The procedure was completed with a different device.No patient complications reported and the patient's condition is good.However, device analysis revealed an open hole at the sheath lap joint section of the device.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed a kink was observed in the imaging window assembly at 67.1 cm from femoral marker at the proximal end.An open hole 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.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, no image appeared in the system due to electrical open at proximal.No imaging core windup was 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: 3979302
• MDR Text Key: 4888872
• Report Number: 2134265-2014-04510
• 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: 07/09/2014

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: 04/17/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16905705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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