MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 5MM X 12CM

Catalog Number	MFR140512
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Procode: krd/hcg.Initial reporter phone: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.The company is seeking this information through the event investigation.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01049.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by an affiliate, when using a mfr140512 coil (mfr140512, l14136) as the first coil and a deltaxsft10 (dlx100306, l14759) as a third coil, detach failure was encountered while detaching both coils.When the physician tried to detach the coil with an enpower control cable (ecb00018200, l14798), the beeping sound was normal (connection light was also ok).But during retrieving delivery system, it continuously came out along the delivery system.The enpower detachable control box (dcb2000500, l12008) and the connecting cable were changed to new ones.But the changed ones also showed detach failures.Both coils were barely detached after 5~7 times of detach trials.The surgery was delayed due to the reported event by 20~25 minutes.The procedure was successfully completed.The two enpower detachable control boxes and one control cable is available for analysis.One control cable was discarded at the hospital.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device l14136 number, and no non-conformances related to the reported complaint condition were identified.Complaint conclusion: as reported by an affiliate, when using a mfr140512 coil (mfr140512, l14136) as the first coil and a deltaxsft10 (dlx100306, l14759) as a third coil, detach failure was encountered while detaching both coils.When the physician tried to detach the coil with an enpower control cable (ecb00018200, l14798), the beeping sound was normal (connection light was also ok).But during retrieving delivery system, it continuously came out along the delivery system.The enpower detachable control box (dcb2000500, l12008) and the connecting cable were changed to new ones.But the changed ones also showed detach failures.Both coils were barely detached after 5~7 times of detach trials.The surgery was delayed due to the reported event by 20~25 minutes.The procedure was successfully completed.Multiple attempts to obtain product for analysis and obtain additional information were unsuccessful.The device has not been returned for analysis and therefore no further investigation can be performed at this time.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.With the information available and without the product available for analysis, the reported customer complaint of ¿coil- failure to detach" could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The ifu states to verify that the microcoil delivery system is fully connected, and no faults are indicted on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re-sheathing the microcoil system, and replace with a new microcoil system.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MICRUSFRAME14 5MM X 12CM
• Common Device Name: MICRUSFRAME
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8692497
• Report Number: 3008114965-2019-01048
• Device Sequence Number: 16732795
• Product Code: KRD
• UDI-Device Identifier: 10886704077992
• UDI-Public: 10886704077992
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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 Expiration Date: 09/30/2021
• Device Catalogue Number: MFR140512
• Device Lot Number: L14136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DETACHMENT CONTROL BOX; ENPOWER CONTROL CABLE