MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB; CATHETER, BILIARY, DIAGNOSTIC

Model Number	32900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that suture was broken on the device.A 8.3/25 expel drainage catheter with twist-loc hub was selected for use.During preparation, the suture fixing the catheter tip was disconnected inside the catheter.The procedure was completed with another of same device.No complications reported.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Device evaluated by manufacturer: unit returned with its original pouch and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.It was observed that the suture string was separated at the proximal section as initially reported.The remainder of the catheter was in good condition.
Event or Problem Description
It was reported that suture was broken on the device.A 8.3/25 expel drainage catheter with twist-loc hub was selected for use.During preparation, the suture fixing the catheter tip was disconnected inside the catheter.The procedure was completed with another of same device.No complications reported.

• Brand Name: EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8612453
• Report Number: 2134265-2019-05293
• Device Sequence Number: 2523046
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0022180082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR