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

Model Number M001FG000240

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that catheter fracture occurred vascular access was obtained from same side of the common iliac artery (cia) utilizing retrograde approach.The 90% stenosed target lesion was located in a moderately tortuous and moderately cia.An atlantis 018 imaging catheter was used to visualize the specified lesion.After crossing the unspecified guidewire, pre-dilatation was performed with an unspecified balloon catheter and imaging was performed.However, when the express ld stent was deployed, imaging was attempted but failed to perform as the device was fractured.The procedure was completed with another of the same device.No patient complications reported and patient's condition is good.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for evaluation.Evaluation of the returned device revealed that there were no issues or damage observed along the length of the sheath assembly.Impedance testing shows an electrical open at proximal wave form.During image characterization testing, no image appeared in the system due to electrical open at proximal.Imaging core wind up in the telescope assembly was observed during x-ray analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a supplier design constraint of the product.(b)(4).

Event Description

It was reported that catheter fracture occurred.Vascular access was obtained from same side of the common iliac artery (cia) utilizing retrograde approach.The 90% stenosed target lesion was located in a moderately tortuous and moderately cia.An atlantis¿ 018 imaging catheter was used to visualize the specified lesion.After crossing the unspecified guidewire, pre-dilatation was performed with an unspecified balloon catheter and imaging was performed.However, when the express¿ ld stent was deployed, imaging was attempted but failed to perform as the device was fractured.The procedure was completed with another of the same device.No patient complications reported and patient's condition 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: 5317346
• MDR Text Key: 34078831
• Report Number: 2134265-2015-08927
• 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,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2016
• Device Model Number: M001FG000240
• Device Catalogue Number: FG000-24
• Device Lot Number: 18100918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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