MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SXPP1B454
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure -no further information is available.On what tissue was the suture placed? the stratafix was used to close the stapled common hole.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? no further information is available.Was the fixation tab intact when the suture was placed in the patient? no further information is available.Other relevant patient history/ concomitant medications? no further information is available.Will the product be returned for analysis? no sample will be returned.
Event or Problem Description
It was reported that a patient underwent a laparoscopic gastrectomy procedure on (b)(6) 2019 and barbed suture was used.The barbed suture was used to close the stapled common hole by continuous suturing during anastomosis between the esophagus and jejunum.Suturing was done as per the recommended method, and two back stitches were put at the end of suturing.The surgeon judged that the suturing with the barbed suture was performed properly.Then, the surgery was completed.After the surgery, an anastomotic leakage occurred.Continuous drainage was started.Drainage was originally performed, but drainage was performed longer than the scheduled period due to a suture failure.The length of hospital stay is extended.At present, there is no danger of life.Patient is in the hospital but progress is good.According to the surgeon, there is a tendency that sutures with smooth barbs ¿move back¿.The surgeon opines that the anastomotic leakage was caused by the barbed suture.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/29/2020.Additional information: h4, h6.A manufacturing record evaluation was performed for the finished device batch pgj794, sxpp1b454 and no non-conformances were identified.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9478588
• Report Number: 2210968-2019-90975
• Device Sequence Number: 10827817
• Product Code: NEW
• UDI-Device Identifier: 10705031240841
• UDI-Public: 10705031240841
• Combination Product (Y/N): N
• PMA/510(K) Number: K182873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: SXPP1B454
• Device Catalogue Number: SXPP1B454
• Device Lot Number: PGJ794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention