MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10020230
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.Physical manufacturer 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 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 (s10531) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 or Problem Description
The healthcare professional reported that during the procedure, the physician could not advance nor retrieve the 2mm x 2cm deltapaq 10 cerecyte coil (cdf10020230 / s10531).As a result, the physician had to remove both the coil and the microcatheter.The coil was inspected after removal and was noted to be stretched.The physician used another 2mm x 2cm deltapaq 10 cerecyte coil to successfully complete the procedure.There was no report of any patient complication or adverse event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 10/03/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure, the physician could not advance nor retrieve the 2mm x 2cm deltapaq 10 cerecyte coil (cdf10020230 / s10531).As a result, the physician had to remove both the coil and the microcatheter.The coil was inspected after removal and was noted to be stretched.The physician used another 2mm x 2cm deltapaq 10 cerecyte coil to successfully complete the procedure.There was no report of any patient complication or adverse event.The product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the 2mm x 2cm deltapaq 10 cerecyte coil was returned and received contained in a pouch.Visual inspection was performed.The hub was inspected and was noted without any appearance of damage.The device positioning unit (dpu) was kinked at 67.2 cm from the proximal end.The coil introducer was zipped and without any appearance of damage.The resheathing tool was also observed to be in good condition.Microscopic inspection was performed.The v-notch was in good condition, with no appearance of damage.The resistance heating (rh) was in good condition.The embolic coil was also observed without any damage.A review of manufacturing documentation associated with this lot (s10531) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Functional test was performed.A lab sample prowler select plus microcatheter was flushed with a lab sample syringe.The 2mm x 4 cm deltapaq 10 cerecyte coil was then introduced into the microcatheter, and although the dpu was kinked, the device was able to advance.A slight resistance/friction was experienced.The reported issue that the coil delivery system was impeded in the microcatheter was not confirmed through the functional test performed on the returned device.The device was able to advance through the lab sample microcatheter with a slight resistance/friction.In addition, the embolic coil was also observed to be in good condition and not stretched as reported.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that three attempts were made to obtain additional information and the product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.[conclusion]: the healthcare professional reported that during the procedure, the physician could not advance nor retrieve the 2mm x 2cm deltapaq 10 cerecyte coil (cdf10020230 / s10531).As a result, the physician had to remove both the coil and the microcatheter.The coil was inspected after removal and was noted to be stretched.The physician used another 2mm x 2cm deltapaq 10 cerecyte coil to successfully complete the procedure.There was no report of any patient complication or adverse event.Multiple attempts to obtain product for analysis and obtain additional information were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.A review of manufacturing documentation associated with this lot (s10531) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Coil stretching is known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue as stretching from occurring.With the limited information available and without the device available for analysis, the reported customer complaint could not be confirmed.The exact cause of the reported event could not be conclusively determined; however, it is possible that when the physician removed the coil after it could not advance nor be retracted/retrieved, the coil could have become stretched during the removal.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 2mm x 2cm deltapaq 10 cerecyte coil left the manufacturing facility with the embolic coil in a stretched condition.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.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.

• Brand Name: DELTAPAQ CERE 2MMX2CM
• 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: 8889438
• Report Number: 3008114965-2019-01120
• Device Sequence Number: 11451912
• Product Code: HCG
• UDI-Device Identifier: 00878528007067
• UDI-Public: 00878528007067
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 04/30/2021
• Device Catalogue Number: CDF10020230
• Device Lot Number: S10531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 10/03/2019; 10/07/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/12/2019; 10/03/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1