MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number 25335

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a foreign object was present.The target lesion was located in the shunt limb.An encore 26 inflation device was selected for use.During preparation, upon unpacking, a foreign object was noted.There was something like thread in it.Also, the three-way stopcock was not locked.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that a foreign object was present.The target lesion was located in the shunt limb.An encore 26 inflation device was selected for use.During preparation, upon unpacking, a foreign object was noted.There was something like thread in it.Also, the three-way stopcock was not locked.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1-initial reporter city: (b)(6) device evaluated by mfr: the device was returned for analysis.A hair was entrapped in the unit gauge/housing.No more issues nor damages were encountered in the inspected device.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10143582
• MDR Text Key: 194814708
• Report Number: 2134265-2020-07630
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729183624
• UDI-Public: 08714729183624
• Combination Product (y/n): N
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: 11/17/2021
• Device Model Number: 25335
• Device Catalogue Number: 25335
• Device Lot Number: 0024787464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1