MAUDE Adverse Event Report: SEE H10 DELTAPAQ CERE 2MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10021030

Device Problems Kinked (1339); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by an affiliate, there was a ¿re-sheath failure¿ to a deltapaq cere coil delivery system (cdf10021030, c38178).There was no patient injury reported.The product will be returned for analysis.Per the product analysis, damage was found to the coil.The deltapaq cere coil delivery system was returned for analysis.A majority of the device is sheathed.The embolic coil is advanced out of the introducer and is tangled around the coiled device positioning unit (dpu).The device was carefully untangled.There are bends in the dpu core wire approximately 20 cm, 135 cm, and 155 cm from the proximal end.The bends at approximately 135 cm and 155 cm are sheathed.The ball tip is intact.The embolic coil is kinked and stretched.The articulating joint is intact.The resistance heating (rh) coil has not heated.The extended coil section of the dpu is kinked at the distal end of the green introducer.The v-notch of the resheathing tool is undamaged.Retraction of the embolic coil into the introducer was attempted.The embolic coil was successfully retracted into the green introducer.Resheathing of the remainder of the device was attempted.There is a kink in the translucent introducer sheath; at the kink, the translucent introducer sheath is unable to re-form around the dpu core wire, and the core wire protrudes.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of rezipping difficulty is confirmed.The device was returned with a kink in the translucent introducer sheath.The kinked section is unable to re-form around the dpu core wire, and the core wire protrudes in the vicinity of the kink.Bends in the dpu core wire are indicative of the application of excessive force to the device.Excessive force did not need to be applied to retract the embolic coil into the introducer or to resheath the device.However, due to the damage to the embolic coil, resistance would be felt if an attempt was made to advance the embolic coil back out of the introducer, and excessive force might be applied in that attempt.100% of devices are inspected in-process by advancing the embolic coil out of the introducer and retracting it back in.Damage to the embolic coil sufficient to cause resistance to advancement would be caught at this point.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Since the embolic coil was advanced out of the introducer when returned, the source of the damage cannot be identified.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Event Description

As reported by an affiliate, there was a ¿re-sheath failure¿ to a deltapaq cere coil delivery system (cdf10021030, c38178).It is unknown if there was any patient injury.The product will be returned for analysis.Per the product analysis, damage was found to the coil.

Manufacturer Narrative

Product complaint # (b)(4).(b)(6).The following information was received, this was a coil embolization of the middle cerebral artery (mca).It was a saccular 3mm aneurysm.The product was stored, inspected and prepped per instructions for use (ifu).The coil was successfully removed from the patient.The coil was not stretched when it was removed and it was still attached to the delivery system when it was removed.There was no additional intervention required.The event did not result in interruption of blood flow.Complaint conclusion updated with additional information: as reported by an affiliate, there was a ¿re-sheath failure¿ to a deltapaq cere coil delivery system (cdf10021030, c38178).There was no patient injury reported.Per the product analysis, damage was found to the coil.The following information was received, this was a coil embolization of the middle cerebral artery (mca).It was a saccular 3mm aneurysm.The product was stored, inspected and prepped per instructions for use (ifu).The coil was successfully removed from the patient.The coil was not stretched when it was removed and it was still attached to the delivery system when it was removed.There was no additional intervention required.The event did not result in interruption of blood flow.The deltapaq cere coil delivery system was returned for analysis.A majority of the device is sheathed.The embolic coil is advanced out of the introducer and is tangled around the coiled device positioning unit (dpu).The device was carefully untangled.There are bends in the dpu core wire approximately 20 cm, 135 cm, and 155 cm from the proximal end.The bends at approximately 135 cm and 155 cm are sheathed.The ball tip is intact.The embolic coil is kinked and stretched.The articulating joint is intact.The resistance heating (rh) coil has not heated.The extended coil section of the dpu is kinked at the distal end of the green introducer.The v-notch of the resheathing tool is undamaged.Retraction of the embolic coil into the introducer was attempted.The embolic coil was successfully retracted into the green introducer.Resheathing of the remainder of the device was attempted.There is a kink in the translucent introducer sheath; at the kink, the translucent introducer sheath is unable to re-form around the dpu core wire, and the core wire protrudes.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of rezipping difficulty is confirmed.The device was returned with a kink in the translucent introducer sheath.The kinked section is unable to re-form around the dpu core wire, and the core wire protrudes in the vicinity of the kink.Bends in the dpu core wire are indicative of the application of excessive force to the device.Excessive force did not need to be applied to retract the embolic coil into the introducer or to resheath the device.However, due to the damage to the embolic coil, resistance would be felt if an attempt was made to advance the embolic coil back out of the introducer, and excessive force might be applied in that attempt.100% of devices are inspected in-process by advancing the embolic coil out of the introducer and retracting it back in.Damage to the embolic coil sufficient to cause resistance to advancement would be caught at this point.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Since the embolic coil was advanced out of the introducer when returned, the source of the damage cannot be identified.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: DELTAPAQ CERE 2MMX10CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H10; 47709 fremont blvd; freemont CA 94538
• MDR Report Key: 7356486
• MDR Text Key: 103290794
• Report Number: 3008114965-2018-00552
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007111
• UDI-Public: 00878528007111
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CDF10021030
• Device Lot Number: C38178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2018
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1