MAUDE Adverse Event Report: SEE H.10 DELTAPAQ 2.5MMX8CM SR PLAT; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DFS10025820
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(fremont).Initial reporter information such as the name, phone and email address are unknown.[conclusion]: the healthcare professional reported that the deltapaq 10 stretch resistant coil 2.5mm x 8cm (dfs10025820 / p11442) was defective.There was no report of patient injury or consequence.Investigation summary: the device was returned with the label from its inner pouch.Information on the label matches the product documented in the complaint.The embolic coil is fully advanced out of the introducer and tangled around the device positioning unit (dpu).The device was carefully untangled.The extended coil section of the dpu is kinked.The device is fully sheathed.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.The embolic coil is kinked.The proximal end of the embolic coil is stretched.The articulating joint is intact.The resistance heating (rh) coil has not heated.The v-notch of the resheathing tool is undamaged.A review of manufacturing documentation associated with this lot (p11442) 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.Investigation conclusion: the complaint that the device is damaged is confirmed.The embolic coil is kinked and stretched.The circumstances surrounding the reported event are unknown.However, stretching is generally caused by the application of excessive force during retraction when resistance is present.The cause of the resistance cannot be identified from the condition of the returned device.Since the embolic coil was advanced out of the introducer as returned, it is also possible that some of the observed damage occurred after the reported event, such as during storage and/or shipping.100% of devices are inspected for the condition of the embolic coil during final assembly per mps-prp0246 rev.9.Thus, it is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.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.Device history lot = > a review of manufacturing documentation associated with this lot (p11442) 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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
The healthcare professional reported that the deltapaq 10 stretch resistant coil 2.5mm x 8cm (dfs10025820 / p11442) was defective.There was no report of patient injury or consequence.

• Brand Name: DELTAPAQ 2.5MMX8CM SR PLAT
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; chemin-blanc 38; fremont CA 94538
• MDR Report Key: 7712579
• Report Number: 3008114965-2018-00686
• Device Sequence Number: 805902
• Product Code: KRD
• UDI-Device Identifier: 00878528007654
• UDI-Public: 00878528007654
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: 11/30/2020
• Device Catalogue Number: DFS10025820
• Device Lot Number: P11442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1