MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8706H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: - please confirm the quantity of suture needle "pop off" that occurred during this procedure.How many for 8706h and how many for ep8706h? - please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) the scrub tech that was present in the case, carrie, said ¿several¿ of the traditional and ¿several¿ of the everpoint needles popped off.All of the sutures used in the case were sent for evaluation.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-07613, 2210968-2023-07614, 2210968-2023-.
Event or Problem Description
It was reported that a patient underwent an impella insertion procedure on (b)(6) 2023 and suture was used.During the procedure, while suturing unknown tissue the needle of two sutures codes popped off.This happened multiple times throughout the procedure.Needle was never unaccounted for.Additional sutures were used to continue with the procedure.The procedure was completed successfully with no adverse consequences for the patient.All suture used in the case is being returned including the affected sutures.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/31/2023.H6 component code: g07002 pending evaluation of returned device.A device has been received, however clarification is requested whether the product belongs to this complaint.The following additional information was requested: 1.Could you please clarify if all the additional devices belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure for all the returned devices? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction for each returned device.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(4) with the ups, dhl or fedex tracker number.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 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: could you please clarify if all the additional devices belong to this complaint? complaint is only for product codes ep8706h and 8706h.If yes, did a device malfunction occur during the same procedure for all the returned devices? no.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.No, just couldn¿t be separate.If the device was not reported before, please provide more details of device malfunction for each returned device.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Additional product does not belong to any complaint.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(4) with the ups, dhl or fedex tracker number.

• Brand Name: PRLNE BLU 30IN 6-0 D/A C-1 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: 17909535
• Report Number: 2210968-2023-07616
• Device Sequence Number: 7497553
• Product Code: GAW
• UDI-Device Identifier: 10705031218949
• UDI-Public: 10705031218949
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2023

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: EP8706H
• Device Lot Number: TEBCMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/13/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/31/2023; 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown