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

Model Number H749518080

Device Problems Peeled/Delaminated (1454); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was reported that coating issue occurred.An opticross¿ imaging catheter was used to view the proximal right circumflex artery.During the percutaneous coronary intervention (pci) procedure disconnect error message was displayed several times, it was also noted that there was white material on the y connector.The white material might be from the femoral marker or the scale marks which was peeled away.The procedure was completed with another of the same device.No patient complications were reported and patient's condition is good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: examination revealed that the device was returned with a white particle, the most distal femoral marker partially peeled in sheath assembly, no damages or failures were observed on the ccp board assembly, the catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be related to a supplier manufacturing issue.(b)(4).

Event Description

It was reported that coating issue occurred.An opticross¿ imaging catheter was used to view the proximal right circumflex artery.During the percutaneous coronary intervention(pci) procedure disconnect error message was displayed several times, it was also noted that there was white material on the y connector.The white material might be from the femoral marker or the scale marks which was peeled away.The procedure was completed with another of the same device.No patient complications were reported and patient's condition is good.

• 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: 4700251
• MDR Text Key: 22054446
• Report Number: 2134265-2015-02278
• 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,Followup
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17577733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1