MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X30IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8755
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2024 and suture was used.The suture broke during the surgical suturing process which prolonged the surgery time and increased the amount of bleeding.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 device not returned.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 is the patient¿s current health status and condition? -stable.How much blood did the patient lost? confirm the qty in cc.How was the bleeding treated? was any blood transfusion necessary? unknown how long was the delay? please specify in minutes.About 10 minutes was there any change in the patient¿s post-operative care due to the prolonged procedure? no please confirm, how many devices demonstrated the alleged deficiency (".The suture broke multiple times during the surgical suturing process.")? 6 please confirm, how many devices demonstrated the alleged deficiency (".The problem of pulling off suture needle happened.") ? none did the needle fall into the patient? if so, please provide the following information: - were x-rays taken to locate the needle? - was the needle piece removed from the patient during the same procedure? a.Does the needle remain in the patient¿s tissue? b."what tissue structure is it located? size of the needle retained c.Are any plans in place to remove the needle piece in future?" - if retained, what is the surgeon's opinion of consequences to the patient? the needle did not fall into the patient name of procedure? coronary artery bypass grafting.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/3/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: received information as following from sales rep via phone today.After investigation, the patient was a 64-year-old male who underwent surgery in jiangsu provincial people's hospital on december 17, 2024 (specific patient diagnosis and name of surgery were unknown).The operator used the suture (epm8755) for suturing and hemostasis during the surgery (the specific suturing tissue level and suturing method were unknown).The problem of pulling off suture needle and suture breakage occurred several times during the suturing (the specific situation was unknown).The operator replaced with other batches of suture (the specific batch information was unknown) to continue suturing.The subsequent surgery went smoothly.This event led to increased intraoperative blood loss (the specific amount of increased blood loss was unknown) and prolonged operation time (the specific extension time was unknown).No subsequent adverse event report was received.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.Please confirm procedure was a cabg.Please confirm 6 sutures broke during this procedure.Please confirm 0 sutures had a suture needle pull off.If the above information is not correct, please explain.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/2/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, the following was obtained: please confirm procedure was a cabg.Please confirm 6 sutures broke during this procedure.Please confirm 0 sutures had a suture needle pull off.If the above information is not correct, please explain.--received information as following from sales rep via phone today.Please refer to the additional event information mentioned on note((b)(4)), other information requested is unknown.Corrected information: h6.

• Brand Name: PRLNE BLU 2X30IN 7-0 D/A BV175-8 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21118818
• Report Number: 2210968-2025-00334
• Device Sequence Number: 21012416
• Product Code: GAW
• UDI-Device Identifier: 10705031203709
• UDI-Public: (01)10705031203709(17)290228(10)UCBDZJ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EPM8755
• Device Lot Number: UCBDZJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 02/02/2025; 02/14/2025; 03/12/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/03/2025; 03/11/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male