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

Catalog Number SXPP1B420

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch number: batch ljq196; mfg date 8/31/2017; exp date 7/31/2019.In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.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 condition of the peritoneum tissue where suture was used (normal, diseased, weakened)? no information.What is the surgeon opinion as to relationship of the stratafix suture and the patient symptoms of ileus? the surgeon is not sure if there was relationship of the stratafix suture and the patient symptoms of ileus.Can you explain which tissue ¿possibility that the tissue was cut with the stratafix as if it was cut by a fret saw¿? the side of the stratafix is jaggy like a fretsaw (or a jigsaw.) the surgeon thinks the tissue might have been cut by the jaggy side of the stratafix.Can you describe the appearance of the suture during the second procedure? it was not broken.It was not escaped from the tissue.Was the suture intact and pulled through the tissue? the suture was intact.But it was not pulled through the tissue.During the re-operation was there any association between the bowel loop and stratafix spiral suture? it was not sure if there was association between the bowel loop and stratafix spiral suture.The reason is as follows.The bowel loop occurred because the peritoneum was torn.However, it is unknown if the stratafix caused the peritoneum to be torn.Can you obtain the lot number of the stratafix spiral suture? possible lot:ljq196 what is the current condition of the patient? no information.

Event Description

It was reported that the patient underwent transabdominal preperitoneal repair on (b)(6) 2018 and barbed suture was used on the peritoneum.On (b)(6) 2018, the abdomen got swollen.By ct inspection, it was found that ileus occurred because a part of the bowel had got into the abdominal wall through the torn area of the peritoneum.On (b)(6) 2018, reoperation was performed laparoscopically.It was found that the part of the peritoneum sutured with barbed suture had been torn.The bowel was relocated to the correct position and the peritoneum was closed.It was reported that it is unknown if there was a causal relationship between the device and the event.The suture was not broken and was not escaped from the tissues.It was reported there is a possibility that the tissue was cut with the barbed suture as if it was cut by a fret saw.The surgeon opined the tissue might have been cut by the jaggy side of the device.It was also reported there is a possibility that the surgeon closed the wound too tightly.It was reported there is a possibility that peeling was not done properly or tension might have been applied to the peritoneum because the peritoneum had adhered to the sigmoid colon.The patient is in the hospital.Additional information has been 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7463162
• MDR Text Key: 106584824
• Report Number: 2210968-2018-72334
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235809
• UDI-Public: 10705031235809
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2018
• 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