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 05/20/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 29jun2014.It was reported that catheter kink and lost image occurred.The 90% stenosed, mildly calcified, moderately tortuous target lesion was located in the middle of the left anterior descending artery.During a percutaneous coronary intervention, an opticross¿ imaging catheter was used.When attempting to cross the lesion, resistance was encountered.Therefore the catheter was pushed and then the catheter as kinked which caused the loss of image.The procedure was completed with another with same 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.(b)(4).Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed the telescope assembly was not able to properly pull back, advance, or retract.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.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.During image characterization testing, no image appeared in the system due to electrical open at proximal.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.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: 3952371
• MDR Text Key: 4643530
• Report Number: 2134265-2014-04505
• 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: 06/29/2014

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: 03/13/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16815305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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