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

Model Number H749364560

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a crack in the device was observed.During preparation, an atlantis¿ pv imaging catheter was selected.However, it was noted that the atlantis¿ pv imaging catheter had a crack in it and fluid sprayed out when flushed.No patient involved.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The unit returned has the plunger of the 3ml syringe bent.No cracks or leaks were observed when the accessory kit and catheter was flushed during testing (using a test plunger).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that a crack in the device was observed.During preparation, an atlantis pv imaging catheter was selected.However, it was noted that the atlantis pv imaging catheter had a crack in it and fluid sprayed out when flushed.No patient involved.

• Brand Name: ATLANTIS¿ PV
• 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: 5169464
• MDR Text Key: 29009082
• Report Number: 2134265-2015-07171
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2016
• Device Model Number: H749364560
• Device Catalogue Number: 36456
• Device Lot Number: 18109672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1