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

Model Number H749518080

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on (b)(4) 2014.It was reported that resistance was encountered during procedure and a kink in the catheter was noted.The 99% stenosed target lesion was located in the severely calcified and moderately tortuous proximal to middle left anterior descending (lad) artery.During the percutaneous coronary intervention (pci) procedure, an opticross¿imaging catheter was used to visualize the target lesion, however, resistance was encountered.The physician then removed the catheter from the patient and noted a kink in the device.The procedure was then completed using another of the same device.No patient complications were reported and the patient's status is good.However, after device analysis it was revealed that there was an open hole at the sheath lap joint section of the device.

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was received for evaluation.Device analysis revealed kinks in the telescope assembly at 70.6 cm and 65.5 cm from femoral marker to the proximal end.The telescope assembly was not able to properly pull back, advance, or retract.The telescope cannot advance the transducer distal housing (tdh) to the most distal position.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.During image characterization testing, no image appeared in the system due to electrical open at proximal.No indication of resistance in tracking the test guidewire (0.014") into the catheter was noted.Imaging core windup was found within the telescope section of the device.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 is operational context as device performance was limited due to anatomical procedural factors.(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: 4077406
• MDR Text Key: 18575933
• Report Number: 2134265-2014-05334
• 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: 08/14/2014

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: 03/18/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16825354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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: BALLOON CATHETER: LACROSS 15MM X 2.5MM (GOODMAN); GUIDE WIRE: SION BLACK (ASAHI INTECC); INTRODUCER SHEATH: 6F SHEATH (TERUMO); GUIDING CATHETER: HYPERION 6F JL4 (ASAHI INTECC)