MAUDE Adverse Event Report: PRESIDIO 18 CERE 8MMX30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC418083030

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by an affiliate, during a coil embolization to an unknown site, a deltapl cere coil (cpl10015230, c27809) and a presidio 18 cere ((b)(4), unknown lot number) pre-detached when the coils were advancing through microcatheter (mc).The physician removed two coils safely from the mc and used another same size coils.There was no repot of patient injury.The products will be returned for analysis.

Manufacturer Narrative

Additional information received indicated that this was a coil embolization to an un-ruptured aneurysm in the piarachnoid.The target vessel characteristics are unknown.The devices were stored, inspected and prepped per instructions for use (ifu).The devices did not kink or bend at any time prior to the resistance/friction.The concomitant devices used with the products did not kink or bend at any time.Adequate continuous flush was maintained through the catheter.These coils were removed when the physician realized coils were pre-detached in the headway 17 microcatheter and no damages on any part of the devices were noted.The same mc was used with both coils and the same mc was used to complete the procedure.There was no additional intervention required.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Product complaint # (b)(4).The following sections have been updated on this supplemental mdr report: d10, g4, g7, h2 and h6.Complaint conclusion: as reported by an affiliate, during a coil embolization to an unknown site, a deltapl cere coil (cpl10015230, c27809) and a presidio 18 cere (pc418083030, unknown lot number) pre-detached when the coils were advancing through microcatheter (mc).The physician removed two coils safely from the mc and used another same size coils.There was no repot of patient injury.Additional information received indicated that this was a coil embolization to an un-ruptured aneurysm in the paraclinoid.The target vessel characteristics are unknown.The devices were stored, inspected and prepped per instructions for use (ifu).The devices did not kink or bend at any time prior to the resistance/friction.The concomitant devices used with the products did not kink or bend at any time.Adequate continuous flush was maintained through the catheter.These coils were removed when the physician realized coils were pre-detached in the headway 17 microcatheter and no damages on any part of the devices were noted.The same mc was used with both coils and the same mc was used to complete the procedure.There was no additional intervention required.(b)(6): approximately 1.5 cm of embolic coil is advanced out of the green introducer.The proximal end of the embolic coil and the distal end of the device positioning unit (dpu) are protruding from the skive of the translucent introducer sheath.The re-sheathing tool is broken.There is a slight amount of blood in the translucent introducer sheath.There are bends or kinks in the dpu core wire at the strain relief and approximately 7 cm, 42 cm, 61 cm, 65 cm, 77 cm, 80 cm, 88 cm, 93 cm, 105 cm, 140 cm, 147 cm, and 178 cm from the proximal end.The ball tip is intact.The embolic coil is kinked and stretched where it is protruded from the skive of the translucent introducer sheath.The articulating joint is intact.The resistance heating (rh) coil has not heated.While the re-sheathing tool is broken, its v-notch is undamaged.Resistance measured 51.1 , which is within the specification range of 48.5 ¿ 56.0.The device was connected to detachment control box dcb000005-00 (dcb) c38341 with a standard connecting cable, and the power was turned on.The system ready light illuminated.The lot number of the device is unknown.Without the lot number, manufacturing information cannot be reviewed.The complaint of premature detachment is not confirmed.The embolic coil was returned attached to the dpu.The kinks and bends in the dpu core wire are indicative of the application of excessive force, possibly in an attempt to overcome resistance.Although resistance was not reported, the embolic coil is anchored in and protruding from the skive of the translucent introducer sheath, and the protruding embolic coil is stretched and kinked.The protruding embolic coil is evidence that the re-sheathing tool was advanced over the embolic coil while unsheathing the device.The ifu (lcn 51844-001 rev.C) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the re-sheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the re-sheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.It is unknown whether patient factors or procedural techniques may have contributed to the reported event.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.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: PRESIDIO 18 CERE 8MMX30CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7226684
• MDR Text Key: 98973818
• Report Number: 3008114965-2018-00520
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC418083030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1