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

Model Number H749518080

Device Problems Entrapment of Device (1212); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that guidewire exit port was kinked and the device became stuck.The opticross¿ imaging catheter used to visualized 80% stenosed target lesion located in the severely tortuous and moderately calcified distal left anterior descending artery.During percutaneous coronary intervention, when this device was advanced, the guidewire exit port was kinked and it became stuck with an unknown guidewire.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition is good.However, returned device analysis revealed an open hole at the sheath lap joint section of the device.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was returned for evaluation.A kink was observed in the distal tip assembly at 98.3cm from femoral marker at the distal end.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.Open hole was observed at the lapjoint sheath assembly.Fluid was leaking from an open hole in the sheath lap joint 72.5 cm from the femoral marker at the distal end when the catheter was flushed.There was no damage observed on the distal tip or guidewire exit port assembly.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 in the roller coaster model, a good square image appeared in the system and the product performed within specification.Ic windup was not found in the telescope assembly.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: 4034013
• MDR Text Key: 4802519
• Report Number: 2134265-2014-05009
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

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: 06/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/25/2014
• 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