MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CF0308
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: krd/hcg.Udi: (b)(4).The device has been returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a g2 complex fill coil stretched after the first optical inspection while pulling it back into the introducer sheath.The coil was not used on the patient and had been stored correctly.When advancing the dpu wire through the introducer sheath to inspect the coil, it moved smoothly through the sheath with no resistance.When the coil was exposed, there were no kinks, burrs, stretching striations or other damaged noticed.There were no known factors that may have contributed to the coil stretching.The procedure was completed with a same/like product with no patient injury or significant delay reported.It was reported that the product would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, a g2 complex fill coil stretched after the first optical inspection while pulling it back into the introducer sheath.The coil was not used on the patient and had been stored correctly.When advancing the dpu wire through the introducer sheath to inspect the coil, it moved smoothly through the sheath with no resistance.When the coil was exposed, there were no kinks, burrs, stretching striations or other damaged noticed.There were no known factors that may have contributed to the coil stretching.The procedure was completed with a same/like product with no patient injury or significant delay reported.It was reported that the product would be returned for analysis.The device was returned for analysis.As viewed through the returned packaging, the coil was found to be partially protruding outside the distal tip of the green introducer.The protruding coil was found to be knotted and entangled outside the distal tip of the green introducer.Two sections of damage were found to the knotted section of the coil.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The coil stretching was confirmed.The most likely root cause of the coils damage that occurred during the coils retraction back inside the green introducer was due to the coil becoming knotted and entangled which anchored the coil preventing complete retraction into the green introducer.The anchored and knotted coil prevented retraction into the green introducer and may have caused the damage found to the coil.Historically it has been found that a quick retraction of the coil into the green introducer can contribute to coil damage, however the circumstances that produced the coils knotting and entanglement which led to the coils damage cannot be determined.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6356116
• Report Number: 2954740-2017-00038
• Device Sequence Number: 1503424
• Product Code: HCG
• UDI-Device Identifier: 10878528009488
• UDI-Public: (01)10878528009488(17)201231(10)P11528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

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: 12/31/2020
• Device Catalogue Number: 641CF0308
• Device Lot Number: P11528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 03/02/2017
• Patient Sequence Number: 1