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

Model Number H749518080

Device Problems Kinked (1339); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 06oct2014.It was reported that a catheter kinked and outer telescope tubing detachment occurred.During a percutaneous coronary intervention (pci), an opticross¿ imaging catheter was selected to visualize an unspecified vessel.When the device was unpacked, it was noted that the guidewire exit port was kinked.Furthermore, the connection of the anchor seal housing was found detached without any physician contact on the device component.Moreover, it was also noted that the outer (female) telescope tubing between the anchor seal and the distal strain relief of the device was detached.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 the lap joint section of the device was damaged and a hole was observed.

Manufacturer Narrative

(b)(4).The complaint device was returned for evaluation.Device analysis revealed that the lap joint section was damaged when the device was received.During handling of the device during the decontamination process, the imaging window became detached from the blue sheath assembly.No damage was observed at the guidewire exit port or at the distal tip assembly.No kinks were observed along the length of the catheter.The telescope female tubing was found detached from the anchor seal assembly.The telescope cannot advance the transducer distal housing (tdh) to the most distal position due to the detachments.Full image characterization cannot be performed due to the telescope and imaging window detachment.The detachment exposes the imaging core which might onset a windup when a functional test is performed.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: 4200541
• MDR Text Key: 21881163
• Report Number: 2134265-2014-06127
• 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: 10/06/2014

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: 07/25/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17153603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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