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 Codes	Abscess (1690); Perforation (2001); Sepsis (2067); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported via medwatch #5087974 that a suture detached and remained inside the patient causing perforation and abdominal abscess.The target lesion was located in the abdomen.A 12/25 expel drainage catheter was selected for use to drain an intraabdominal abscess.The suture material used to curl the ir catheter broke off in the patient's abdomen that led to recurrent abscess, infection, bowel perforation and serious life threatening medical problems.There is an ongoing surgical treatment that requires further reconstructive surgery.The bsc expel drainage catheter with twist loc hub 12 french x 25cm was used last 2017 in which the locking suture was broken off and perforated the duodenum and sepsis that was later identified in 2018.There were multiple operations and the patient continues to have significant medical problems related to the detached suture which caused perforation and abdominal abscess.The patient was readmitted in 2017 for further treatment of multiple abdominal abscess in which the back end of the drain was cut, the drain was removed over a short non bsc wire and drainage catheter.Blistering of the skin adjacent to the drain was noted.The locking loop was formed and the positioning was in the abscess.The drain was not sutured or using secure device but was relying ont the locking loop to prevent dislodgement.Instead, gauze and paper tape were to sterilely cover the bsc expel drainage catheter.The catheter was removed and repeat the imaging was performed to ensure appropriate device placement.However, the malfunctioning of the locking mechanism the exchange of another non bsc catheter to was placed.The repeat of ct image was used with statlock system in placed and sterile dressing was applied in 2017.Later in 2018, the discharged with abscess drained with complex open ventral hernia was repaired.Subsequently, the patient was admitted with drainage from the wound.Cultures showed multiple enteric pathogens exploratory lap resection of chronic fistula that caused by bsc drainage catheter suture break.The hernia repair was compromised due to the detached suture eroded into the duodenum and created an abscess, fistula and sepsis breakdown.The patient was discharge.Currently in 2019, patient requires major surgery to repair the hernia.
Event or Problem Description
It was reported via medwatch #5087974 that a suture detached and remained inside the patient causing perforation and abdominal abscess.The target lesion was located in the abdomen.A 12/25 expel drainage catheter was selected for use to drain an intraabdominal abscess.The suture material used to curl the ir catheter broke off in the patient's abdomen that led to recurrent abscess, infection, bowel perforation and serious life threatening medical problems.There is an ongoing surgical treatment that requires further reconstructive surgery.The bsc expel drainage catheter with twist loc hub 12 french x 25cm was used last 2017 in which the locking suture was broken off and perforated the duodenum and sepsis that was later identified in 2018.There were multiple operations and the patient continues to have significant medical problems realted to the detached suture which caused perforation and abdominal abscess.The patient was readmitted in 2017 for further treatment of multiple abdominal abscess in which the back end of the drain was cut, the drain was removed over a short non bsc wire and drainage catheter.Blistering of the skin adjacent to the drain was noted.The locking loop was formed and the positioning was in the abscess.The drain was not sutured or using secure device but was relying ont the locking loop to prevent dislodgement.Instead, gauze and paper tape were to sterilely cover the bsc expel drainage catheter.The catheter was removed and repeat the imaging was performed to ensure appropriate device placement.However, the malfunctioning of the locking mechanism the exchange of another non bsc catheter to was placed.The repeat of ct image was used with statlock system in placed and sterile dressing was applied in 2017.Later in 2018, the discharged with abscess drained with complex open ventral hernia was repaired.Subsequently, the patient was admitted with drainage from the wound.Cultures showed multiple enteric pathogens exploratory lap resection of chronic fistula that caused by bsc drainage catheter suture break.The hernia repair was compromised due to the detached suture eroded into the duodenum and created an abscess, fistula and sepsis breakdown.The patient was discharge.Currently in 2019, patient requires major surgery to repair the hernia.It was further reported that a 10 french catheter was placed and then replaced with a 12 french in (b)(6) 2017.The patient experienced continuing infection, duodenum perforation, intraabdominal abscess, sepsis, multiple surgical procedures, reconstructive surgery, and other maladies.The suture material was found to be 1 cm in length in 2018.
Additional Manufacturer Narrative
1: initial reporter address (b)(6).

• 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: 8903902
• Report Number: 2134265-2019-09800
• Device Sequence Number: 18892773
• Product Code: FGE
• UDI-Device Identifier: 08714729860600
• UDI-Public: 08714729860600
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0019369653
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other