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

Model Number H749518080

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that tore in the guidewire exit port occurred.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous middle left anterior descending artery.During percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used.Upon removal of this device, the unspecified guidewire was entangled with the device's guidewire exit port and was noticed to be torn.No patient complications were reported and the patient's status is good.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device returned to mfr: the device was returned for evaluation.Examination of the returned device revealed kinks in the telescope and tip assembly from femoral marker to the distal end.The telescope assembly was not able to properly pull back, advance, and 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.The guidewire exit port was lifted.During image characterization testing, no image appeared in the system due to electrical open at proximal.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).

Event Description

It was reported that tore in the guidewire exit port occurred.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous middle left anterior descending artery.During percutaneous coronary intervention (pci), an opticross imaging catheter was used.Upon removal of this device, the unspecified guidewire was entangled with the device's guidewire exit port and was noticed to be torn.No patient complications were reported and the patient's status 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3952315
• MDR Text Key: 18034130
• Report Number: 2134265-2014-04248
• 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,Followup
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16853095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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