MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ATLANTIS¿ PV; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number H749364560

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter had a pinhole.The target lesion is located in the popliteal vein.During venogram, the f/g, atlantis pv imaging catheter was selected for use.The catheter got into the patient but the catheter kept star bursting.They took the catheter out in the patients body and tried to flush.However they noticed that the catheter had a pinhole.The procedure was completed using another of the same device.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.No holes or leaks were found during visual inspection.It was observed that the catheter flushed normally during functional inspection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that the catheter had a pinhole.The target lesion is located in the popliteal vein.During venogram, the f/g, atlantis pv imaging catheter was selected for use.The catheter got into the patient but the catheter kept star bursting.They took the catheter out in the patients body and tried to flush.However they noticed that the catheter had a pinhole.The procedure was completed using another of the same device.No patient complications were reported and the patient's status is fine.

• Brand Name: ATLANTIS¿ PV
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5455383
• MDR Text Key: 38855645
• Report Number: 2134265-2016-01084
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: H749364560
• Device Catalogue Number: 36456
• Device Lot Number: 17889859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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