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

Model Number H749518080

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.During a percutaneous coronary intervention, an opticross was used on a mildly calcified lesion located at the left proximal anterior descending artery with 75 percent stenosis.Pre intravascular ultrasound (ivus) was performed before stenting to observe the vessel with this device, however "connect" and "disconnect" messages were displayed several times.When this device was used again during post ivus, "disconnect" message displayed repeatedly.Therefore, the device was exchanged to another opticross to complete 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 found an open hole 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 telescope assembly was able to properly pull back, advance, and retract.The ccp board and pins appeared normal and a good click sound was heard during insertion into the motor drive unit (mdu) system.No disconnect error message was observed during functional testing.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3903196
• MDR Text Key: 4429553
• Report Number: 2134265-2014-03776
• 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: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16716849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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
• Treatment: STENT: XIENCE EXPEDITION / 3.5X15 / AIJ; GUIDEWIRE: NEO'S RINATO / 0.014INCH / AIJ; BALLOON CATHETER: LACROSSENSE / 2.5X13 / GOODMAN; INFLATION DEVICE: EVEREST / MDT; GUIDING CATHETER: HEARTRAIL / 6FR / TERUMO