MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDF100154-30
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being mechanically detached, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00327 and 3008114965-2020-00328.Complaint conclusion: as reported by the field, during a coil embolization, a 1.5mmx4cm deltapaq cere coil (cdf10015430, s13544) impeded in the microcatheter (mc).It was reported that physician found force when he pushed first coil within microcatheter, then he withdrew the first coil outside of the patient.The physician changed to a new 1.5mmx6cm deltapaq cere (cdf10015630, s14515), but still failed to advance.Physician withdrew the second coil outside of patient.He changed to use a galaxy coil and was able to push smoothly within the same mc.The physician implanted a second galaxy coil successfully as well.Therefore, the procedure was completed by the two galaxy coils.There was no patient injury reported.The target cerebral position was not lost.No additional information is available.One non-sterile deltapaq cere 1.5mmx4cm was received inside of a pouch.The received device was visually inspected and no damages could be noted.Then a microscopic inspection was performed, the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.The embolic coil was not returned for analysis and it appear to be mechanically detached from the device.No other damages could be observed.A lab sample prowler select plus was flushed using a lab sample syringe.After that, the unit deltapaq cere 1.5mmx4cm was introduced into a lab sample prowler select plus and it advance, no resistance/friction was felt.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ was not able to confirmed.The device was found in good conditions.Also, the deltapaq cere 1.5mmx4cm was able to advance through the lab sample mc without a problem.The mechanically detached condition noted on the device may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis or the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned 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 the field, during a coil embolization, a 1.5mmx4cm deltapaq cere coil (cdf10015430, s13544) impeded in the microcatheter (mc).It was reported that physician found force when he pushed first coil within microcatheter, then he withdrew the first coil outside of the patient.The physician changed to a new 1.5mmx6cm deltapaq cere (cdf10015630, s14515), but still failed to advance.Physician withdrew the second coil outside of patient.He changed to use a galaxy coil and was able to push smoothly within the same mc.The physician implanted a second galaxy coil successfully as well.Therefore, the procedure was completed by the two galaxy coils.There was no patient injury reported.The target cerebral position was not lost.No additional information is available.Based on the product analysis of the 1.5mmx4cm deltapaq cere, the embolic coil appears to be mechanically detached from the device.

• Brand Name: DELTAPAQ CERE 1.5MMX4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10369065
• Report Number: 3008114965-2020-00327
• Device Sequence Number: 14169495
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: 00878528007036
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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: 02/28/2022
• Device Model Number: CDF100154-30
• Device Catalogue Number: CDF10015430
• Device Lot Number: S13544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1