MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10021030

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

This initial mdr is the only report being submitted for mfr report #2954740-2017-00205.(b)(4).The product has been forwarded to (b)(4) for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that three c-deltapaq coils (cdf100210-30/s10817, cdf100210-30/ s10728 x 2) and an enpower control cable (ecb000182-00/s11989) were used during a coil embolization procedure of an aneurysm for mapca in an abnormal blood vessel of the pulmonary artery when resistance was felt between all three c-deltapaq coils and the hub of the microcatheter.Embolization of the internal thoracic artery branch was performed during the procedure for mapca.The microcatheter was advanced to the target lesion and a pre-deployment electrical check was performed.C-deltapaq coil (complaint product 1) was delivered through the introducer which was connected at the back of the hub.Strong resistance was felt when the introducer was passed through the hub.The coil was removed from the microcatheter and another c-deltapaq coil (complaint product 2) was delivered; however, the same issue occurred.The coil was replaced with a c-deltapaq coil (complaint product 3) and the issue occurred a third time.After that, the procedure was continued using non-micrus coils (target, stryker/azur, terumo clinical supply).The patient was a 3-year-old male whose vessel was mildly tortuous and not calcified.A guidewire (0.014inch cruise, asahi intecc), a guiding catheter (3.2fr nishiya, medikit), a microcatheter (2.4fr sniper, terumo) were also used for this procedure.The procedure was successfully completed without further issues.However, due to the event the procedure was delayed for 30 minutes.There was also no patient injury/complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.There was no damage noted to the c-delatpaq coils prior to use.The c-deltapaq coils will be returned for investigation; the enpower control cable will not be returned.No further information is available.

Manufacturer Narrative

Three devices were returned in the same package and without product packaging or lot number labels.For purposes of this investigation, they will be referred to as device a, device b, and device c.Device a was returned still seated in a non-codman microcatheter.The resheathing tool was advanced all the way to the proximal end of the green introducer.There is blood on the hub of the microcatheter.There is a slight kink in the dpu core wire approximately 53 cm from the end of the strain relief.There is a small amount of staining at the proximal end of the green introducer.An attempt was made to remove the microcoil system from the microcatheter, but it was unsuccessful.Device b was returned with the distal portion of the dpu core wire and part of the embolic coil projecting through the skive of the translucent introducer near the green introducer.There is some staining in the middle of the green introducer.There is a slight kink in the dpu core wire approximately 54 cm from the end of the strain relief, and another very slight kink approximately 2.5 cm from the end of the strain relief.Device c was returned partially sheathed.There is a portion of the embolic coil protruding from the skive in the translucent introducer.There is a small amount of staining at the end of the green introducer.On device a, the staining on the green introducer appears to be blood on the outside of the introducer.There is no apparent damage to the resheathing tool.Because the device cannot be removed from the microcatheter, the embolic coil cannot be examined.On device b, the staining on the green introducer appears to be blood inside the green introducer.The embolic coil is kinked and stretched inside the introducer sheath distal to where the coil and dpu protrude.The portion of the embolic coil that protrudes from the translucent introducer is severely stretched.The suture filament is observable at the proximal end of the embolic coil.There is some plastic remodeling of the v-notch of the resheathing tool.Device c exhibits blood at the distal end of the green introducer and in the translucent introducer.A portion of embolic coil near the proximal end is stretched and protrudes from the translucent introducer.The suture filament is observable in the protruded section of the embolic coil.There is no observable damage to the v-notch in the resheathing tool.Functional testing could not be performed.Device a is firmly adhered to the microcatheter, so neither device a nor the microcatheter are available to test microcoil advancement.Both device b and device c have significant microcoil damage, with the microcoils protruding from the translucent introducer.Dhr review was previously completed for both lots of microcoil mentioned in this complaint.No issues were found during the manufacturing or inspection processes that could be related to the reported complaint.Conclusion: pertaining to device a, the complaint that the device could not be advanced through the microcatheter is confirmed.Device a is firmly adhered within the microcatheter, and can be neither advanced nor retracted.Pertaining to device b and device c, the complaint that each device could not be advanced through the microcatheter could not be confirmed, as the devices were not in appropriate condition for testing.The evidence of blood in the green introducer of all 3 devices is indicative of a situation in which there was insufficient flush maintained.According to the ifu ((b)(4)), ¿it is important that a continuous infusion of an appropriate flush solution be maintained¿ for optimal performance.Insufficient flush allows blood to backflow into the microcatheter and from there into the microcoil system, which generates resistance.The kinked dpu core wires and protrusion of embolic coils (device b and device c) and dpu core wire (device b) are indicative of excessive force being applied to the dpu.While the exact circumstances are unknown, this is likely to have occurred while trying to advance the microcoils past resistance.In addition, both device a and device b show indications that the device was unsheathed further than the position recommended by the ifu (the ifu instructs the user to leave approximately 1 inch of the unsheathed introducer sheath still visible).In device a, the resheathing tool was advanced all the way to the green introducer.In device b, the presence of the distal end of the dpu core wire and the proximal embolic coil outside of the introducer sheath is indicative of the device being unsheathed to the embolic coil, which would have been damaged in the process.A review of the manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product malfunction of impeded is a known potential event associated with these codman devices.Further, while not specifically addressed within the product ifus, surgical delay is a known potential adverse event.Surgical delay in association with product malfunctions is often related to the time a physician takes to trouble shoot or alleviate any events that occur secondary to the product behavior.Review of the available information suggests that intra-procedural issues, device interaction contributed to the reported events.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.There is no current safety signal identified related to the reported event(s) based on review of complaint history for the device.No further actions are required at this time.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6715449
• MDR Text Key: 80119243
• Report Number: 2954740-2017-00205
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007111
• UDI-Public: (01)00878528007111(17)210531(10)S10728
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CDF10021030
• Device Lot Number: S10728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention