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

Model Number H749518080

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

Reportable based on investigation completed on (b)(4) 2015.It was reported that the catheter failed to cross the lesion.The 90% stenosed target lesion was located in the severely tortuous middle of the left anterior descending (lad) artery.During percutaneous coronary intervention (pci) procedure, an opticross¿ imaging catheter was selected to view target lesion.After the unspecified guide catheter was engaged to the vessel, an unspecified guidewire was crossed the lesion.Then an unspecified semi compliant balloon was inserted to dilate the vessel.After which the opticross¿ imaging catheter was advanced, however the imaging catheter failed to cross the lesion.When the device was removed from the patient, it was noted that the device was kinked at the lap joint section.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s condition is good.However, device analysis revealed that there was a partial separation at the lap joint 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 that there was a damage on the guidewire exit port assembly, a kink in the imaging window (lap joint section) at 73cm from the femoral marker to the distal end, a lap joint partial separation in the device, the telescope assembly was not able to properly pull back, advance, or retract due to the lap joint partial separation, fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing and indication of resistance in tracking the guidewire into the catheter when a test guidewire (0.014") was inserted.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4753209
• MDR Text Key: 15232422
• Report Number: 2134265-2015-02575
• 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: 04/09/2015

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: 12/04/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17514472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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