MAUDE Adverse Event Report: SEE H.10 DELTAPAQ 5MMX15CM SR PLAT; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DFS10051520
Medical Device Problem Codes	Separation Failure (2547); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode is krd/hcg.(b)(4).[conclusion]: the healthcare professional reported that during the procedure to isolate the vein which formed a bubble on a (b)(6)-year old male patient with a medical history of arteriovenous fistula, the deltapaq 10 stretch resistant 5mm x 15cm coil (dfs10051520 / s10355) failed to detach at the site of the target lesion.The coil was removed and during removal, the coil became bent and the delivery wire became damaged.It was confirmed that no damage was noted on the device prior to its use during the procedure.The reported issue did not cause any patient adverse event and resulted in no procedural delay.The device is not available to be returned for analysis; the device was discarded.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s10355) 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.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.With the limited information available and without the product available for analysis, the reported customer complaint 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.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.Devices undergo 100% inspection at final assembly for to ensure there is no damage to the embolic coil, the delivery wire and all the device components.Thus, it is not likely that the deltapaq 10 stretch resistant 5mm x 15cm coil left the manufacturing facility with any damage to the embolic coil, the delivery wire or other device components.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2018-00785.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 to isolate the vein which formed a bubble on a (b)(6)-year old male patient with a medical history of arteriovenous fistula, the deltapaq 10 stretch resistant 5mm x 15cm coil (dfs10051520 / s10355) failed to detach at the site of the target lesion.The coil was removed and during removal, the coil became bent and the delivery wire became damaged.It was confirmed that no damage was noted on the device prior to its use during the procedure.The reported issue did not cause any patient adverse event and resulted in no procedural delay.The device is not available to be returned for analysis; the device was discarded.

• Brand Name: DELTAPAQ 5MMX15CM SR PLAT
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8040000
• Report Number: 3008114965-2018-00786
• Device Sequence Number: 13849275
• Product Code: KRD
• UDI-Device Identifier: 00878528007807
• UDI-Public: 00878528007807
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 07/29/2018

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: DFS10051520
• Device Lot Number: S10355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 75