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

Model Number H749518080

Device Problems Failure To Adhere Or Bond (1031); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

Reportable based on investigation completed on 28oct2014.It was reported that the catheter did not connect and disconnect error message was displayed.During a procedure, an opticross¿ imaging catheter was used.During preparation, the connection part between the motordrive unit (mdu5) and the catheter hub was tight and it encountered difficulty in connecting.The physician managed to connect the catheter to the mdu5 still the catheter did not connect completely and "disconnect" message was displayed.The physician tried to disconnect the catheter from the mdu5, but it was tight to remove the catheter.In the end the catheter was able to remove from the mdu5.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).The complaint device was received for evaluation.Based on the returned condition of the device, 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.A kink was observed in the sheath assembly at 23.8cm and 32.2cm from femoral marker to the proximal end.The ccp board and pins appeared normal and a good click sound was heard during insertion into the mdu system.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.No error message was observed during functional testing.During image characterization testing, no image appeared in the system due to electrical open at proximal.Imaging core windup was 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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(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: 4247925
• MDR Text Key: 5046244
• Report Number: 2134265-2014-07019
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17125083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2014
• 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