MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X36IN 5-0 D/A C-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8720
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
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.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.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 provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure name of index surgical procedure? please confirm the date of the initial procedure.Is it (b)(6) 2024 or (b)(6) 2024? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? did the patient experience a wound dehiscence? if yes, what tissue dehisced? were there any patient stress factors that precipitated the event of suture breakage post op? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.What symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.After closing and plating the sternum, blood was profusely pouring out of both ends of the sternal surgical incision.The chest was urgently opened, patient was put back on bypass emergently, and the bleeding was searched for.It was found that a 5-0 suture was broke at the 6 o'clock end and the knot was still intact on one of the promixal grafts.They have looked at all lot numbers and do know have any more of this lot on the shelf.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.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.-male name of index surgical procedure? -cabg please confirm the date of the initial procedure.Is it (b)(6) 2024 or (b)(6) 2024? -1/19 the diagnosis and indication for the index surgical procedure? -coronary artery disease what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? -open sternotomy on what tissue was the suture used? -proximal anastomosis of the harvested vein and aorta what was the tissue condition (normal, thin, calcified, fragile, diseased)? -normal how was the suture placed (interrupted or continuous)? -continuous how was the suture tied (square knot or multiple knots one end)? -surgeons knot did the patient experience a wound dehiscence? -no if yes, what tissue dehisced? were there any patient stress factors that precipitated the event of suture breakage post op? -no onset date/time of dehiscence? (# post op days) -happened intraop how was the dehiscence managed? -surgeon went back in with a new prolene and re-sutured the anastomosis.He also added a few interrupted stitches to secure the anastomosis please describe any surgical intervention required for the wound dehiscence including date and findings.-surgeon had performed the anastomosis, went off pump, and close the sternum.Once the sternum was closed, they noticed bleeding coming from the incision.They opened the sternum and discovered that the prolene suture of the anastomosis had unraveled.They went back on pump and had to re-sew it.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? -no please describe the appearance of the suture during the second procedure.-unraveled completely what symptoms did the patient experience following the index surgical procedure? onset date? -none other relevant patient history/concomitant medications? -none what is the physician¿s opinion as to the etiology of or contributing factors to this event? -he belives the suture unraveled what is the patient's current status? -recovered well if applicable, will product be returned? if so, please provide the return date and tracking information.-no.There were only two eaches of this product on the shelf and they were both used on the field.Corrected information: h6 - health effect - clinical code h6 - health effect - impact code h6 - medical device problem code.

• Brand Name: PRLNE BLU 4X36IN 5-0 D/A C-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 18656303
• Report Number: 2210968-2024-01036
• Device Sequence Number: 12544792
• Product Code: GAW
• UDI-Device Identifier: 10705031045897
• UDI-Public: 10705031045897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M8720
• Device Lot Number: TGBBJK
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male