MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 CERE 10MMX34CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418103430
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
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).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 10mmx34cm presidio 18 cere coil (pc418103430, l14456) stretched in the echelon 10 microcatheter (mc).The physician found the coil couldn¿t advance in microcatheter, then pulled it back outside of the patient with the microcatheter together.Changed to a new catheter (still use an echelon 10) and a new 10mm x 20mm competitor¿s coil to complete the operation successfully.After the operation, the physician pulled the problem coil out of the previous microcatheter, and found the coil already stretched.No patient injured was reported.The target position was lost, because the micro catheter was pulled out side of the patient¿s body and changed to a new catheter.
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 10mmx34cm presidio 18 cere coil ((b)(4), l14456) stretched in the echelon 10 microcatheter (mc).The physician found the coil couldn¿t advance in the microcatheter, then pulled it back outside of the patient with the microcatheter together.Changed to a new catheter (still used an echelon 10) and a new 10mm x 20mm competitor¿s coil to complete the operation successfully.After the operation, the physician pulled the problem coil out of the previous microcatheter, and found the coil already stretched.No patient injury was reported.The target position was lost, because the micro catheter was pulled out side of the patient¿s body and changed to a new catheter.One non-sterile unit presidio 18 cere 10mmx34cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and several kinks were found.The introducer was inspected, and it was found partially zipped 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 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 evaluation.The functional analysis could not be performed due to the conditions of the received device (dpu-several kinked, introducer-kinked).A manufacturing record evaluation was performed for the finished device l14456 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 loss of cerebral target position¿ was not able to evaluate due the conditions of the received device (dpu-several kinked, introducer-kinked).The complaint reported by the customer ¿coil - unraveled/stretched-in microcatheter¿ was not able to be confirmed.The embolic coil was not returned for evaluation.The kinked condition appears 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 nor the mre suggest that the failure reported by the costumer 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 information provided.However, 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.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: PRESIDIO 18 CERE 10MMX34CM
• 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: 9217967
• Report Number: 3008114965-2019-01208
• Device Sequence Number: 13989653
• Product Code: HCG
• UDI-Device Identifier: 00878528003229
• UDI-Public: 00878528003229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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,Followup
• Report Date (Section B): 09/29/2019

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: 10/31/2023
• Device Catalogue Number: PC418103430
• Device Lot Number: L14456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 09/29/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: MEDTRONICS ECHELON 10 MICROCATHETER