MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPP1B450

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Blood Loss (2597); Not Applicable (3189); No Code Available (3191)

Event Date 05/28/2018

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: what was the date of the initial procedure? in (b)(6), 2018.The date is unknown.What was the condition of the vaginal tissue where suture was used (normal, diseased, weakened)? no information.Can you explain ¿stratafix was used by ¿double layers continuous suturing¿? two (2) layers were sutured together by continuous suturing.Can you describe how the stratafix spiral suture was placed? no information.Which part of the suture protruded from the vaginal wall? no information.What was the date of the second procedure when suture was removed? (b)(6) 2018.What medical intervention was indicated for the patient bleeding? the doctor only removed the suture because oozing was very small.Can you describe the appearance of the suture during the second procedure? no information.Was the suture that was removed available for evaluation? not available.Does the surgeon believe the suture caused/and or contributed to the bleeding and protrusion? yes.What is the current condition of the patient? the patient visits the hospital regularly.

Event Description

It was reported that patient underwent total laparoscopic hysterectomy on unknown date in (b)(6) 2018 and barbed suture was used to close the vaginal stump with continuous suturing on two layers of tissue.On (b)(6) 2018 the patient returned to hospital due to vaginal bleeding.The surgeon noted barbed suture protruding from vaginal wall with oozing.An additional procedure was performed to remove the barbed suture.The surgeon opined that the bleeding worsened due to protruded barbed suture.The patient continues to follow up at the hospital for observation.Additional information was requested.

• Brand Name: STRATAFIX SPIRAL PDS+
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7626099
• MDR Text Key: 111917046
• Report Number: 2210968-2018-73636
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236219
• UDI-Public: 10705031236219
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention