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

Model Number M001FG000240

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Reportable based on investigation completed on 08dec2014.It was reported that the tip of the catheter was flattened or damaged.The 100% stenosed target lesion was located in the moderately tortuous and calcified superficial femoral artery.During a peripheral percutaneous intervention (ppi), an atlantis¿ 018 imaging catheter was used in order to visualize the target lesion.However, it was noted that the tip of the device was flattened or damaged.Subsequently, a non-bsc guide wire was unable to pass through the imaging catheter.The procedure was then completed using a different device.No patient complications were reported and the patient's status is good.However, after device analysis it was found out that the distal tip assembly was broken and missing.

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).The complaint device was received for evaluation.After device analysis, the following were observed: a kink was observed in the sheath assembly at 20.0cm from femoral marker to the distal end.The distal tip assembly was broken off and missing approximately 3.0mm long during investigation.The broken distal tip assembly appeared stretched and neckdown was observed at the ro marker distal end.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.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: 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: 4358422
• MDR Text Key: 20659607
• Report Number: 2134265-2014-07962
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2014

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: 04/04/2015
• Device Model Number: M001FG000240
• Device Catalogue Number: FG000-24
• Device Lot Number: 16872560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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: GUIDE WIRE: TREASURE XS (ST.JUDE MEDICAL); INTRODUCER SHEATH: DESTINATION (TERUMO)