MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ 9MMX25CM SR PLAT; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DFS10092520
Medical Device Problem Code	Material Deformation (2976)
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
Product complaint: (b)(4).Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., (b)(4).The facility name and customer contact information were not reported.Physical manufacturer name: codman and shurtleff inc., (b)(4).
Event or Problem Description
As reported by the (b)(6), during use of a 9mm x 25cm deltapaq ((b)(4) thermo-mechanical coil, compression of the ¿spring¿ was noted, making it impossible to ¿progress¿.There was no report of consequence or impact to the patient.It was reported that the information provided for this complaint was all of the details that were known/available regarding this event.The product is not available for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).The complainant that reported this event to the brazilian health authority (anvisa) is anonymous.As the complainant is anonymous, it is not possible to obtain additional event information or the product for analysis.[complaint conclusion] as reported by the (b)(6) authority (anvisa), during use of a 9mm x 25cm deltapaq (dfs10092520/s10053) thermo-mechanical coil, compression of the ¿spring¿ was noted, making it impossible to ¿progress¿.There was no report of consequence or impact to the patient.It was reported that the information provided for this complaint was all of the details that were known/available regarding this event.The product was not returned for evaluation.A review of manufacturing documentation associated with this lot 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.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 manufacturing process of the unit.Damage to the embolic coil is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu states the following: ¿visually examine the microcoil for any anomalies such as kinks, burrs, stretched coil, striations, or other damages.If any anomalies are noted or if there is difficulty advancing the microcoil from the introducer sheath, the unit may be defective.Repackage the microcoil and return the entire device for replacement.¿ assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.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.

• Brand Name: DELTAPAQ 9MMX25CM SR PLAT
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8080680
• Report Number: 3008114965-2018-00809
• Device Sequence Number: 1692154
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1