MAUDE Adverse Event Report: ETHICON INC. CATGUT PLAIN 2-0 70CM (1)BB; SUTURE, ABSORBABLE, NATURAL

Catalog Number A2414T

Device Problem Detachment Of Device Component (1104)

Patient Problem Not Applicable (3189)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/05/2018.(b)(4).Attempts have been made to retrieve the device.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: what was the size of the needle used? needle size 17mm.Was whole needle or part of needle retained in the patient? whole needle.Did the needle physically break at (swage, central portion of needle, tip of needle) or did the whole needle separate /pull off from the suture? no.The whole needle uncoupled from the suture.Were any measures were taken to retrieve the needle? if yes, please specify what was done? yes.The surgeon dissected the right parapharyngeal region in an attempt to retrieve the needle without success.Thus she closed it and sent the patient to perform an image examination (tomography).Was there any additional tissue damage as a result of searching for the needle? no.Are there any plans to remove the needle? if yes, please indicate date - yes.Patient is being followed weekly in the office and will perform a new tomography scan on (b)(6).He will perform an x-ray examination weekly to follow the displacement of the needle.According to the surgeon, the operated region takes about 3 months to heal completely.Therefore, if the needle does not move until it reaches a more superficial tissue plane to provide an outpatient withdrawal, a new procedure will be performed to remove it.The date of the procedure will be after (b)(6).Any patient consequences or ae report? no consequences have been reported so far.The doctor said only that the family is very apprehensive and frightened by what happened.This is an (b)(6) patient.The needle is housed, according to the tomography ct scan, in the region of the 3rd right upper molar.Has there been any medical or surgical intervention performed? yes.As the procedure was performed at a day hospital, the patient was referred to a pediatric hospital and was observed for more than 36 hours after the procedure.It was also necessary to use broad spectrum antibiotic therapy as a precaution due to foreign body housing.Patient¿s current condition? according to the surgeon, the patient is stable.He is feeling pain in the operated region, but the doctor informed that the pain is normal in the immediate postoperative period (procedure performed on (b)(6) 2018).The doctor informed the family that the pain can not be associated with the needle housing yet since the procedure is still recent and they should wait a little longer before having conclusions.In the attached e-mail, there are the tomography image.There will be a procedure to take out the needle out, after that it will be sent for analysis.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Has an additional procedure been performed to retrieve the needle? please provide details of any medical or surgical intervention performed? is the actual sample being returned for analysis? are any unopened representative samples of the same lot being returned for analysis?.

Event Description

It was reported that a patient underwent adenotonsillectomy procedure on (b)(6) 2018 and suture was used.The needle separated from the suture.The surgeon dissected the right parapharyngeal region in an attempt to retrieve the needle without success.The surgeon closed it and sent the patient to perform an image examination (tomography).The tomography ct scan identified the needle in the region of the 3rd right upper molar.The patient was hospitalized for 36 hour observation.The patient is being followed weekly for x-ray examination to follow the displacement of the needle.The surgeon reported that if the needle does not move until it reaches a more superficial tissue plane to provide an outpatient withdrawal, a new procedure will be performed to remove it.The patient is listed in stable condition at home and prescribed broad spectrum antibiotic therapy as a precaution due to foreign body.Additional information has been requested.

Manufacturer Narrative

Representative samples were returned for evaluation.They were visually and functionally examined for diameter, length, needle pull and knot tensile strength and they met the finished goods requirements.

• Brand Name: CATGUT PLAIN 2-0 70CM (1)BB
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC. BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7241304
• MDR Text Key: 99025881
• Report Number: 2210968-2018-70660
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: A2414T
• Device Lot Number: AH6506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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
• Patient Age: 11 YR