MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 3MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10031030

Device Problems Stretched (1601); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(fremont).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (c35111) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2019-00999.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during the coil embolization procedure, the 3 mm x 10 cm deltapaq 10 cerecyte coil (cdf10031030 / c35111) was the coil chosen to start the procedure, but the coil could not be completely deployed out of the microcatheter.The coil was replaced with the 5mm x 15cm deltapaq 10 cerecyte coil (cdf10051530 / s14517), and the same issue occurred.There was no report of any patient injury or complication.The products are available to be returned for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2019.The additional event information resulted in a change in the reportability of this complaint.[additional information]: the healthcare professional reported that during the coil embolization procedure of an aneurysm at the carotid syphon, the 3 mm x 10 cm deltapaq 10 cerecyte coil (cdf10031030 / c35111) was the first coil chosen to start the procedure, but the coil could not be introduced into the headway® microcatheter (microvention-terumo).The coil was replaced with the 5mm x 15cm deltapaq 10 cerecyte coil (cdf10051530 / s14517), and the same issue occurred; the coil could not be introduced into the microcatheter.When the coil was removed, it was still attached to the delivery system.It was reported that adequate and continuous flush was maintained through the microcatheter; the same microcatheter was used to complete the procedure using stryker coils.The event resulted in a 20-minute delay, but it was not considered clinically significant.There was no report of any patient injury or complication.Upon further review, this complaint does not meet the criteria for medical device reporting since the coil could not be introduced into the microcatheter.Therefore, it has been deemed not reportable.No further reports will be forthcoming.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2019-00999.

Manufacturer Narrative

Product complaint # (b)(4).The purpose of this mdr follow up #2 submission is to report the emboli coil stretch that was noted during the device investigation.Updated sections: d10, g4, g7, h2 and h6.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a healthcare professional reported that during a coil embolization to the carotid syphon and after the first coil was chosen to start the procedure, there was friction encountered during the advancement of a 3 mm x 10 cm deltapaq 10 cerecyte coil (cdf10031030 / c35111) through a microvention/terumo microcatheter (mc).It was not possible to enter in the mc.The device was replaced with a 5mm x 15cm deltapaq 10 cerecyte coil (cdf10051530 / s14517), and the same issue occurred.Both coils were still attached to the delivery system when removed from the patient.The procedure was completed successfully with the same mc and with a non-cerenovus coil.The procedure was prolonged by 20 minutes; however, it was not considered as clinically significant.The event did not require that the microcatheter be removed.The procedure was prolonged by 20 minutes; however, it was not considered as clinically significant.There was no patient injury reported.Adequate and continuous flush was maintained through the microcatheter.A non-sterile unit deltapaq cere 3mmx10cm was received inside of a pouch.The hub was not received with the unit for analysis.Only a part of the dpu was received and it was found broken.The introducer was inspected, and it was found with residues of dry blood inside.The re-sheating tool was inspected and it was found in good conditions.The v-notch was inspected under microscope and it was found in normal good condition.The rh was inspected under microscope it was found without damage as well was no heated.The embolic coil was inspected under microscope and it was found stretched and protruded from the introducer.The functional analysis could not be performed due the device was not received with all components.A manufacturing record evaluation was performed for the finished device c35111 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¿ could not be duplicated due the conditions observed on the device.The complaint reported by the customer was not able to evaluate due the conditions of the received device.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.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter 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.

• Brand Name: DELTAPAQ CERE 3MMX10CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8588428
• MDR Text Key: 204093100
• Report Number: 3008114965-2019-01000
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007210
• UDI-Public: 00878528007210
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CDF10031030
• Device Lot Number: C35111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 05/09/2019; 07/04/2019
• Supplement Dates FDA Received: 05/21/2019; 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROVENTION MICROCATHETER
• Patient Age: 65 YR