MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Not Applicable (3189)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure age: (b)(6).Gender: f.Weight: -.Bmi: 59.3%.Date and name of the index surgical procedure.(b)(6).Gastric sleeve.The diagnosis and indication for the index surgical procedure? morbid obese.On what tissue was the suture used? unknown.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? normal.How was the suture placed, interrupted or continuous? continuous.What were current symptoms following the index surgical procedure? onset date? she was admitted to whittier pres.Hospital for gastric pain.Ct scan they confirmed questionable fluid collection.On november 18, transferred the patient to (b)(6) hospital.Ct scan revealed large air fluid collection adjacent to the spleen.How was the anastomotic leak confirmed? ct scan.Was surgical intervention performed? if yes, date? diagnostic laparoscopic and placement of drain performed at (b)(6) on (b)(6).Patient was then transferred to (b)(6) on (b)(6) for stent placement.What is the patient¿s current status? the patient is at home.The following information was requested but unavailable: please provide date and appearance of the suture during the second procedure? other relevant patient history/concomitant medications.Product code? lot number? if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event note: event related to (b)(6) 2019 diagnostic laparoscopic and placement of drain reported via mw#2210968-2019-90938; event related to (b)(6) 2019 stent placement reported via mw.

Event Description

It was reported that a patient underwent a bariatric gastric sleeve procedure on (b)(6) 2019 and suture was used.Post-op, the patient presented at the local er with gastric pain.Ct scan confirmed questionable fluid collection.On (b)(6) 2019, the patient was transferred to another hospital.Ct scan revealed a large air fluid collection adjacent to the spleen.It was discovered there was an anastomotic leak.On (b)(6) 2019, the patient underwent diagnostic laparoscopic placement of a drain.The patient was transferred to another hospital on (b)(6) 2019 for stent placement.The patient is currently at home.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9644248
• MDR Text Key: 189693019
• Report Number: 2210968-2020-00808
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR