MAUDE Adverse Event Report: AESCULAP AG PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM; CEREBRO VASCULAR CLIPS

Model Number FE908K

Device Problem Failure to Seal (4070)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That an phynox avm clip app fcps tub shaft90mm (part# fe908k) was used during a procedure on december 11 2023.According to the complainant the clips were staying open after being loaded into the patient.Reportedly the patient was returned to the operating room after the procedure and 3 more clips were implanted for the second time.There were seven attempts at implanting in total where the clips were staying open.The adverse event is filed under aic reference xc (b)(4).400634273 (2916714-2023-00142) fe964k.400634274 (2916714-2023-00143) fe964k 400634275 (2916714-2023-00144) fe963k 400634276 (2916714-2023-00145) fe963k 400634277 (2916714-2023-00146) fe962k 400634278 (2916714-2023-00147) fe963k 400634279 (2916714-2023-00148) fe953k.

Event Description

Additional information was received: the device was used during an open craniotomy for arteriovenous malformation (avm) resection procedure.The surgeon attempted to place four (4) clips during the original procedure.The patient was returned to the operating room (or) on (b)(6) 2023, and three (3) additional clips were used without success.Therefore, seven clips failed to function properly; clips remained open.The procedure was able to be successfully completed using aneurysm clips.The surgeon indicated that there was "no direct harm" to patient, but estimated that there was an additional "one hour of anesthesia time" and noted the "need for additional dissection of scar tissue to identify the appropriate location since a clip could not be used as a radiographic marker." the patient's current condition was reported as "doing well." the adverse event is filed under aic reference xc (b)(4).(b)(4) (2916714-2023-00142) fe964k (b)(4) (2916714-2023-00143) fe964k (b)(4) (2916714-2023-00144) fe963k (b)(4) (2916714-2023-00145) fe963k (b)(4) (2916714-2023-00146) fe962k (b)(4) (2916714-2023-00147) fe963k (b)(4) (2916714-2023-00148) fe953k.

Manufacturer Narrative

Additional information: b5 - description updated.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Investigation results: the manufacturer has performed a gauge test for the applier and the results were not according to specification.In addition, a spot weld was found on the collet, indicating that the device had been improperly repaired.An unauthorized stamp was discovered on the instrument, which does not originate from aesculap ag.According to the manufacturer, collets must not be welded, but must be replaced during maintenance if a deviation is detected on the component.Due to the deviations on the pliers, proper functioning of the clips can no longer be guaranteed.It cannot be ruled out that the deformation of the clips has been caused by the damaged pliers.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: based upon the above-mentioned investigation results, a definitive root cause for the reported issue could not be established.In general, the instructions for use (ifu) must be considered to avoid malfunction or damage to the clips.Incorrect insertion of the clips into the clip-on pliers can lead to damage.Furthermore, sign of a third-party repair has been detected on the applier, so a proper function of the applier cannot be guaranteed.

• Brand Name: PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18409070
• MDR Text Key: 331497496
• Report Number: 2916714-2023-00149
• Device Sequence Number: 1
• Product Code: HCH
• UDI-Device Identifier: 04038653385966
• UDI-Public: 4038653385966
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2023,04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE908K
• Device Catalogue Number: FE908K
• Device Lot Number: 2380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Distributor Facility Aware Date: 12/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention