MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 3MMX4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10030430
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 (b)(4).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 3mmx4cm deltapaq cere (cdf10030430, l13129) was not able to advance nor retrieved by the physician.The physician pulled the coil 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 # = > pc-(b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization, a 3mmx4cm deltapaq cere (cdf10030430, l13129) was not able to be advanced nor retrieved by the physician.The physician pulled the coil 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 product for analysis and obtain additional information were unsuccessful.The device will not be returned for analysis and therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13129 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - unraveled/stretched-in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.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.
Additional Manufacturer Narrative
(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with product analysis: as reported by a healthcare professional, during a coil embolization, a 3mmx4cm deltapaq cere (cdf10030430, l13129) was not able to be advanced nor retrieved by the physician.The physician pulled the coil 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 product for analysis and obtain additional information were unsuccessful.One non-sterile unit deltapaq cere 3mmx4cm 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 in good conditions.The introducer was inspected, and it was found separated from unit.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 was inspected under microscope and it was found in good conditions.The embolic coil was inspected under microscope and it was found stretched.The functional analysis could not be performed due to the introducer was found separated from unit.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 evaluate due the conditions of the received device (introducer separated from unit).The complaint reported by the customer ¿coil - unraveled/stretched-in microcatheter¿ was confirmed due to the embolic coil was found stretched.The stretched 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 event 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.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.

• Brand Name: DELTAPAQ CERE 3MMX4CM
• 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: 8875316
• Report Number: 3008114965-2019-01127
• Device Sequence Number: 11360433
• Product Code: HCG
• UDI-Device Identifier: 00878528007180
• UDI-Public: 00878528007180
• Combination Product (Y/N): N
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 06/30/2023
• Device Catalogue Number: CDF10030430
• Device Lot Number: L13129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 10/15/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/26/2019; 10/21/2019
• 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.