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

Catalog Number	CDF10015430
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
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 1.5mmx4cm deltapaq cere coil (cdf10015430, s12651) was being used as the first coil, however, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unknown microcatheter 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 report of patient injury.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization, a 1.5mmx4cm deltapaq cere coil (cdf10015430, s12651) was being used as the first coil, however, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unknown microcatheter 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 report of patient injury.One non-sterile unit deltapaq cere 1.5mmx4cm 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 protruded from the introducer.The introducer was inspected, and it was found partially zipped, kinked and with residues of dry blood inside.The re-sheathing tool was inspected, and it was found broken in two.The v-notch was inspected under microscope and no damages were noted on it.The rh was inspected under microscope and it was found in good conditions.The embolic coil was inspected under microscope and it was with no damages on it.The functional analysis could not be performed due to the conditions of the received device (re-sheathing tool broken in two).A manufacturing record evaluation was performed for the finished device s12651 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 (re-sheathing tool broken in two).The complaint reported by the customer ¿coil - unraveled/stretched-in microcatheter¿ was not able to confirm due no damages were found on the embolic coil.The broken 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.Assignment of root cause for the events remains speculative and inconclusive, based on the limited 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 issues.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; 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.Multiple attempts to obtain additional information were unsuccessful.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 9147504
• Report Number: 3008114965-2019-01191
• Device Sequence Number: 2752781
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: 00878528007036
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 10/31/2021
• Device Catalogue Number: CDF10015430
• Device Lot Number: S12651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: UNKNOWN MICROCATHETER