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

Model Number H749518080

Device Problems Entrapment of Device (1212); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2015

Event Type  Injury  

Event Description

It was reported that the guidewire exit port got stuck in lesion.The 4.5x40mm, 90% stenosed target lesion was located in severely calcified and moderately tortuous right coronary artery (rca).During a percutaneous coronary imaging (pci), an opticross¿ imaging catheter was used in order to visualize the target lesion.However, after a pre-intravenous ultrasound was performed, a resistance was encountered when the catheter was attempted to be removed.Furthermore, the guidwire exit port of the imaging catheter got stuck in the severely calcified target lesion.And in order to resolve the issue, the physician removed the transducer of the imaging catheter and inserted a non-bsc guidewire; but to no success, the opticross¿ imaging catheter was unable to be removed.So, a non-bsc guidewire was then advanced to the lesion where the imaging catheter got stuck; by such means, the opticross¿ imaging catheter was then successfully removed.Moreover, after the imaging catheter was removed, it was noted that the distal tip of the device was kinked.The procedure was then completed using a different device.No patient complications were reported and the patient¿s status is good.

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental mdr will be filed.(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: 4835186
• MDR Text Key: 15829027
• Report Number: 2134265-2015-03658
• 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: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17794383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• 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: GC: 6FR HYPERION; GW: SION BLACK
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR