MAUDE Adverse Event Report: SEE H.10 DELTAPAQ 9MMX25CM SR PLAT; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DFS10092520
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding date of birth, age, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter information such as phone and email address are not available / unknown.[conclusion]: the healthcare professional reported that during the coil embolization of a short neck splenic artery aneurysm, the 9mm x 25cm deltapaq 10 stretch resistant coil (dfs10092520 / s10053) was chosen after previous coils were advanced and placed through the prowler select plus microcatheter.The deltapaq 10 stretch resistance coil became impeded in the distal third of the microcatheter and could not be advanced to the target lesion.The coil was removed to be returned for evaluation and analysis.There was no report of any patient consequence or adverse event associated with the event.The 9mm x 25cm deltapaq 10 stretch resistant coil was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 9mm x 25cm deltapaq 10 stretch resistant coil was received contained in a pouch.The hub and the device positioning unit (dpu) were inspected and found to be in normal good condition without any damage.The resheathing tool and the introducer were not returned.The returned device underwent microscopic inspection.The resistance heating (rh) and the articulation join were inspected through the microscope and found to be without damage.The rh was not heated.The embolic coil was found kinked and in stretched condition.Without the coil introducer and with the observed condition of the embolic coil, functional analysis was not able to be performed and the issue reported in the complaint that the coil became impeded in the distal third of the microcatheter and could not be advanced was not confirmed through functional analysis of the returned device.A review of manufacturing documentation associated with this lot (s10053) 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.Coil kinked and stretched are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink and stretching from occurring.The coil kinked and stretched conditions were not originally reported with the complaint.The exact cause of the observed kinked and stretched condition of the embolic coil could not be conclusively determined; however, excessive force may have been inadvertently applied during the procedural handling of the device and/or during the interaction with the concomitant microcatheter.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 9mm x 25cm deltapaq 10 stretch resistant coil left the manufacturing facility with the embolic coil in the stretched/tangled condition observed on the returned device.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.
Event or Problem Description
The healthcare professional reported that during the coil embolization of a short neck splenic artery aneurysm, the 9mm x 25cm deltapaq 10 stretch resistant coil (dfs10092520 / s10053) was chosen after previous coils were advanced and placed through the prowler select plus microcatheter.The deltapaq 10 stretch resistance coil became impeded in the distal third of the microcatheter and could not be advanced to the target lesion.The coil was removed to be returned for evaluation and analysis.There was no report of any patient consequence or adverse event associated with the event.The 9mm x 25cm deltapaq 10 stretch resistant coil was returned for evaluation which revealed that the embolic coil was kinked and stretched.Based on the product analysis completed on 3/19/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPAQ 9MMX25CM SR PLAT
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8450154
• Report Number: 3008114965-2019-00968
• Device Sequence Number: 2926490
• Product Code: KRD
• UDI-Device Identifier: 00878528007968
• UDI-Public: 00878528007968
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 03/31/2021
• Device Catalogue Number: DFS10092520
• Device Lot Number: S10053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1