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

Model Number H749518080

Device Problems Hole In Material (1293); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that the catheter was kinked and had a hole.During preparation for percutaneous coronary intervention (pci), it was noted that the connecting section of the opticross¿ imaging catheter, on the proximal shaft of the telescope and the sheath, was kinked and had a hole.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed a hole at the sheath lap joint area of the catheter.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that a kink was observed in the sheath assembly at 12.0 cm 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.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.Impedance testing finds that there was no electrical disconnect in the imaging circuit.Full image characterization cannot be performed due to the hole at the lap joint seam between the imaging window and blue sheath tubing.This hole prevents the device to be flushed properly and it tends to bend a little that could interfere with the proper rotation of the imaging core.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4093355
• MDR Text Key: 18064289
• Report Number: 2134265-2014-05477
• 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: 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: 05/31/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17013022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• 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: 05/31/2014
• 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