MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS¿ 018; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M001FG000240

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older (b)(4).Device evaluated by mfr: 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 medwatch will be filed.(b)(4).

Event Description

It was reported that catheter got stuck in lesion.Vascular access was obtained with ipsilateral retrograde approach.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified external iliac artery (eia).A 40mhzh atlantis¿ 018 imaging catheter was selected to view target lesion.During procedure, a non bsc guide wire was advanced to the target lesion.Then the atlantis¿ imaging catheter was used;however it was noted that the device got stuck at the lesion.The physician pushed the imaging catheter and lost image occurred.Dilatation was then performed with an unspecified balloon and the imaging catheter was exchanged to another of the same device.Finally, stent deployment was performed and good blood flow was confirmed.No patient complications were reported and the patient's status is good.

• Brand Name: ATLANTIS¿ 018
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 5545753
• MDR Text Key: 41819285
• Report Number: 2134265-2016-02618
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K073623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2016
• Device Model Number: M001FG000240
• Device Catalogue Number: FG000-24
• Device Lot Number: 18193914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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