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

Model Number	32900
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection performed.The catheter was returned with the metal cannula and trocar loaded, the cannula was unloaded without issues and a damage was encountered in the pigtail section.A hole was observed in the pigtail section.Functional inspection performed on the metal cannula was inserted through the catheter and no resistance was felt.
Event or Problem Description
Reportable based on device analysis completed on octoer 12, 2020.It was reported that proximal part of cannula spring out from the catheter.A 12/25 expel drainage catheter with twist-loc-hub was selected for use.Upon preparation, it was noted that the proximal part of the cannula spring out from the catheter when inserted.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a hole in the pigtail section.

• 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: 10778341
• Report Number: 2134265-2020-15110
• Device Sequence Number: 19744224
• Product Code: FGE
• UDI-Device Identifier: 08714729860600
• UDI-Public: 08714729860600
• 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
• Report Date (Section B): 11/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0024477040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR