MAUDE Adverse Event Report: ETHICON INC. MERSILENE SUTURE 12"(30CM) 5-0 WHT; CLASS I DEVICE - EXEMPT

Catalog Number	RS21
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Erosion (1750); Premature Labor (2465); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: j.Obstet.Gynaecol.Res.Vol.36, no.1: 209¿212, february 2010; doi:10.1111/j.1447-0756.2009.01097.X.(b)(4).
Event or Problem Description
It was reported via journal article "title: translocation of a cerclage band into the endocervical canal after preconception transabdominal cervico-isthmic cerclage" authors: moon-il park and jeong-kyu hoh.Citation: j.Obstet.Gynaecol.Res.Vol.36, no.1: 209¿212, february 2010; doi:10.1111/j.1447-0756.2009.01097.X.This study aimed to present a (b)(6) year-old female patient who had history of five spontaneous losses and failure of two mcdonald purse-string cerclages, who underwent transabdominal cervico-isthmic cerclage (tcc) for incompetent cervix as a management of recurrent second-trimester pregnancy loss and preterm delivery.In the procedure, the posterior peritoneum was punctured with an aneurysm needle, passing a single strip of #5 mersilene band (0.5 cm wide, mersilene 5, rs21, ethicon, inc.Nj, usa) from the posterior to the anterior side.The procedure then was repeated on the contralateral side using the same piece of mersilene band.The mersilene band was adjusted to lie flat over the posterior peritoneum at the level of the origin of the uterosacral ligaments.Then it was tied anteriorly causing compression without undue constriction of the intervening tissue.Her seventh pregnancy was uncomplicated, but a migration of about one third of the mersilene band was found into the cervical canal.Cerclage band was not removed as patient wanted further pregnancy.Her further pregnancy reached 33 weeks¿ gestation due to preterm labor without any signs of infection.Both tubal ligations were performed, and the cerclage band was removed at this time.Although it could have been a case of pure coincidence of preterm labor, we take a chance to speculate that the migration of the cerclage band into the endocervical canal might have been the reason for the preterm labor.

• Brand Name: MERSILENE SUTURE 12"(30CM) 5-0 WHT
• Common Device Name: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8204371
• Report Number: 2210968-2018-78079
• Device Sequence Number: 18881304
• Product Code: KDC
• UDI-Device Identifier: 10705031049789
• UDI-Public: 10705031049789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: Health Professional
• Device Catalogue Number: RS21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR