MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FILL COIL 7X21; ORBIT GALAXY

Catalog Number	640CF0721
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization of the right posterior communicating artery (pcom), the user experienced major resistance while advancing a 7x21 og tdl cmplx fill (640cf0721, 17710989) as the second coil into the sl-10 microcatheter (mc).At this point he check the tightness of the rhv on the shuttle.He removed the coil from the patient and inspected the coil and the delivery tube and nothing seemed unusual.Then a 7x21 og tdl cmplx fill coil (640cf0721, 17722907) was implanted normally and the procedure was successfully completed.There was no loss of cerebral target position.There were no patient consequences reported.The surgery was delayed three to four minutes.A 6f cook shuttle was used.The sl-10 mc was jailed in the aneurysm by the enterprise stent.The vessels were not tortuous and certainly not calcified.An 8x15 orbit galaxy complex fill was used as the first coil.It was reported that the devices¿ looked intact prior to placement, during placement and after removal¿.When the devices were removed from the patient, there were no damages on any part of the devices.A non-sterile unit og tdl cmplx fill coil 7x21 was received inside of a pouch.The hub was inspected, and no damages was noted on it.The hypo-tube was inspected, and it was found kinked at 95cm from proximal end.The introducer was inspected, and it was found unzipped in good normal conditions, but it was found tangled with the embolic coil.The support coil was inspected under microscope and it was found kinked.The gripper was inspected, and it was found without damages.The embolic coil was inspected under microscope and it was found tangled with the introducer and the support coil, also it was found stretched.The functional analysis could not be performed due the hypo tube was found kink and the support coil was found outside the introducer, also the embolic coil was found tangled with the introducer and the support coil.A manufacturing record evaluation was performed for the finished device 17710989 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿ could not be evaluated due the conditions noted on the device (embolic coil tangled, hypo-tube/support coil kinked).The kinked condition noted on the hypo-tube and the stretched noted may have contributed to the failure and appear to have been caused by excessive handling and force being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the 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 instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of the right posterior communicating artery (pcom), the user experienced major resistance while advancing a 7x21 og tdl cmplx fill (640cf0721, 17710989) as the second coil into the sl-10 microcatheter (mc).At this point he check the tightness of the rhv on the shuttle.He removed the coil and inspected the coil and the delivery tube and nothing seemed unusual.Then a 7x21 og tdl cmplx fill coil (640cf0721, 17722907) was implanted normally and the procedure was successfully completed.There was no loss of cerebral target position.There were no patient consequences reported.The surgery was delayed three to four minutes.A 6f cook shuttle was used.The sl-10 mc was jailed in the aneurysm by the enterprise stent.The vessels were not tortuous and certainly not calcified.An 8x15 orbit galaxy complex fill was used as the first coil.It was reported that the devices¿ looked intact prior to placement, during placement and after removal¿.When the devices were removed from the patient, there were no damages on any part of the devices.Based on the device investigation, the embolic coil was stretched.

• Brand Name: OG TDL CMPLX FILL COIL 7X21
• Common Device Name: ORBIT GALAXY
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8800171
• Report Number: 1226348-2019-00953
• Device Sequence Number: 3272792
• Product Code: KRD
• UDI-Device Identifier: 10886704030362
• UDI-Public: 10886704030362
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 06/30/2019
• Device Catalogue Number: 640CF0721
• Device Lot Number: 17710989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1