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 Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke.An 8.3/25 expel drainage catheter with twist-loc hub was selected for use.During procedure, it was noted that the suture broke when pulled to deploy the pig tail after inserting.The device was then removed and there were no device fragments left inside the patient's body.A new expel was inserted and completed the procedure.No complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The expel catheter was returned, no defects were noted and it looks in good condition.The suture string was received cut at distal section.The suture looks broken at the section exposed in the pigtail.
Event or Problem Description
It was reported that the suture broke.An 8.3/25 expel drainage catheter with twist-loc hub was selected for use.During procedure, it was noted that the suture broke when pulled to deploy the pig tail after inserting.The device was then removed and there were no device fragments left inside the patient's body.A new expel was inserted and completed the procedure.No complications reported and the patient was stable.

• 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: 9981676
• Report Number: 2134265-2020-05346
• Device Sequence Number: 11721461
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 10/27/2022
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0024669967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1