MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2.5MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10025630
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01124 and 3008114965-2019-01125.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 2.5mmx6cm deltapaq cere (cdf10025630, c40100), a 3mmx6cm deltapaq cerecyte (cdf10030630, s14317) and a 5mmx10cm deltapaq cere (cdf10051030, s11295) were not able to advance nor retrieved by the physician.The physician pulled the coils and microcatheter (mc) at the same time.After inspection it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint#: (b)(4).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, a 2.5mmx6cm deltapaq cere (cdf10025630, c40100), a 3mmx6cm deltapaq cerecyte (cdf10030630, s14317) and a 5mmx10cm deltapaq cere (cdf10051030, s11295) were not able to advance nor retrieved by the physician.The physician pulled the coils and microcatheter (mc) at the same time.After inspection it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.Multiple attempts to obtain additional information were unsuccessful.A non-sterile deltapaq cere 2.5mmx6cm unit was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 0.1cm from the proximal end.The introducer was inspected, and it was unzipped and kinked.The re-sheathing tool was inspected, and it was found in good conditions.The v-notch was inspected under microscope and no damages were noted on it.The rh and the embolic coil were inspected under microscope and no damages were noted on them.Both were found outside from the introducer.Functional testing could not be performed due to the introducer was found unzipped and kinked.A manufacturing record evaluation was performed for the finished device c40100 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 confirmed due the functional test could not be performed due to the introducer was found unzipped and kinked.The complaint reported by the customer ¿coil, unraveled/stretched-in microcatheter¿ was not confirmed due no damages were noted on the embolic coil.The kinked condition appears to have been caused by excessive force and handling being applied to the device and may have contributed to the failure as reported, 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided.It is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue with the coil failing to detach.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.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.

• Brand Name: DELTAPAQ CERE 2.5MMX6CM
• 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: 8874305
• Report Number: 3008114965-2019-01123
• Device Sequence Number: 2742871
• Product Code: HCG
• UDI-Device Identifier: 00878528007142
• UDI-Public: 00878528007142
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 12/31/2020
• Device Catalogue Number: CDF10025630
• Device Lot Number: C40100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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: MICROCATHETER