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

Model Number H749364560

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a pinhole towards the end of the catheter occurred.During a venogram procedure, an atlantis¿ pv imaging catheter was used to visualize an unspecified lesion.When the imaging catheter was flushed outside of patient's body, it was noted that there was a pinhole towards the end of the imaging catheter which allowed more saline solution getting out from the hole instead of coming out from the end of the device.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Correction: device avail.For eval - changed from yes to no.Device returned to mfr.- changed from yes to no.The device received for this complaint did not match the reported batch number.The received device has been reported on mdr id: 2134265-2015-05224.(b)(4).

Event Description

It was reported that a pinhole towards the end of the catheter occurred.During a venogram procedure, an atlantis⠐v imaging catheter was used to visualize an unspecified lesion.When the imaging catheter was flushed outside of patient's body, it was noted that there was a pinhole towards the end of the imaging catheter which allowed more saline solution getting out from the hole instead of coming out from the end of the device.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 4799107
• MDR Text Key: 5881340
• Report Number: 2134265-2015-03181
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2016
• Device Model Number: H749364560
• Device Catalogue Number: 36456
• Device Lot Number: 17787106
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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