MAUDE Adverse Event Report: SEE H.10 GALAXY G3 6MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120610
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Date of event: the event occurred in 2019, however, the date of the event was not reported.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The device lot number is not available/not reported.The expiration date of the device is not known.Initial reporter information such as the name, phone and email address are not available/not reported.The device manufacture date is not known as the device lot number is not available/not reported.Conclusion: the healthcare professional reported that during the procedure, the 6 mm x 10 cm galaxy g3 coil (gly120610/lot# unknown) had difficulty detaching.It took some manipulation by advancing and retracting the coil while pressing the detach button on the detachment control box to finally get the coil to detach successfully on the fifth attempt without any patient consequence.The reported issue caused a two-minute procedural delay.It was also reported that 7 other galaxy coils were successfully detached without any issue on the same patient.There was no adverse event, no other medical intervention reported.The procedure was successfully completed.Based on complaint information, the 6mm x 10cm galaxy g3 coil remains implanted and is thus not available for evaluation.The lot number is not available.Device history record (dhr) review could be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information in the complaint and without the product available for analysis, the reported customer complaint could not be confirmed.Failure to detach is a known potential issue associated with the use of this device.The instruction for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.The cause of the reported difficulty encountered during coil detachment could not be conclusively determined, however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, the 6 mm x 10 cm galaxy g3 coil (gly120610/lot# unknown) had difficulty detaching.It took some manipulation by advancing and retracting the coil while pressing the detach button on the detachment control box to finally get the coil to detach successfully on the fifth attempt without any patient consequence.The reported issue caused a two-minute procedural delay.It was also reported that 7 other galaxy coils were successfully detached without any issue on the same patient.There was no adverse event, no other medical intervention reported.The procedure was successfully completed.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2019.The date of event is (b)(6) 2019.[conclusion]: the healthcare professional reported that during the procedure, the 6 mm x 10 cm galaxy g3 coil (gly120610 / lot# unknown) had difficulty detaching.It took some manipulation by advancing and retracting the coil while pressing the detach button on the detachment control box to finally get the coil to detach successfully on the fifth attempt without any patient consequence and the physician proceeded with the case as normal.The reported issue caused a two-minute procedural delay.It was also reported that 7 other galaxy coils were successfully detached without any issue on the same patient.There was no adverse event, no other medical intervention reported.The procedure was successfully completed, and the patient was reported to have done well.Based on complaint information, the 6mm x 10cm galaxy g3 coil remains implanted and is thus not available for evaluation.The lot number is not available.Device history record (dhr) review could be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information in the complaint and without the product available for analysis, the reported customer complaint could not be confirmed.Failure to detach is a known potential issue associated with the use of this device.The instruction for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.The cause of the reported difficulty encountered during coil detachment could not be conclusively determined, however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: GALAXY G3 6MM X 10CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8295099
• Report Number: 3008114965-2019-00902
• Device Sequence Number: 19266081
• Product Code: KRD
• UDI-Device Identifier: 10886704077527
• UDI-Public: 10886704077527
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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 Catalogue Number: GLY120610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1