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

Model Number H749518080

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 21aug2014.It was reported that shaft kinked occurred.During the preparation to perform a percutaneous coronary intervention, an opticross imaging catheter was used to diagnose an unknown lesion.When setting up this device, the proximal shaft was kinked.The device was exchanged to another of same device to continue the procedure.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

(b)(4).Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed kinks in the sheath assembly from femoral marker to 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.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.The imaging window was still connected to the blue sheath tubing at the lap joint.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: 4092949
• MDR Text Key: 4762804
• Report Number: 2134265-2014-05460
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/21/2014

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: 05/19/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16979076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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