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

Catalog Number	CDX18062530
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: krd.(b)(4).Concomitant medical products: sheath introducer (medikit); guidewire (meister, ashahi intecc); guiding catheter (contrast catheter);micro catheter (masters parkway soft, asahi intecc) manufacturing date unavailable.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the procedure resistance was experienced with the microcatheter when using a deltamaxx coil (cdx18062530/s12585).The coil had also separated and unraveling, and part of the coil remains in the patient.The procedure was delayed by 100 minutes due to the reported event.The procedure was coil embolization of hepatic artery chemoembolization/varicose shunt at the gastric artery.The patient¿s vessel was moderately torturous and not calcified.An approach was made from right femoral artery by hepatic arterial chemoembolization, the guiding catheter and the micro catheter were accessed to the target lesion as a unit.After completion of intubation therapy, a varicose shunt connected from the gastric artery was confirmed with a contrast and coil embolization of the target gastric artery was performed.After accessing with the above system, the first coil a deltamaxx (complaint product) was selected and preparation was performed according to ifu and the coil was inserted by the physician (2nd).However, when two-thirds of the coil was inserted into the micro catheter resistance was experienced.It was difficult to insert the coil; the procedure was changed by the physician (1st).After that, the coil was pushed and pulled several times repeatedly to insert the coil, however since it was difficult the physician tried to remove the coil.The coil separated at the connection part between the coil and the delivery wire.The coil remained between the gastric artery and the inside of the micro catheter, and tail of the coil unraveled from the sheath which was confirmed on the contrast when the micro catheter was removed.The physician tried to withdraw the coil by hand but the coil unraveled and the entire coil could not be withdrawn.Therefore, the physician tried to remove the coil with snare which was inserted along the coil, but the unraveled part of the coil separated during removing, and the coil tip remained in the abdominal aorta and the coil tail remained in the gastric artery.The physician tried to remove the coil by exchanging with another snare (3fr and 6fr), but the unraveled coil part separated.The contralateral approach was made from femoral artery and delivered the contrast catheter to the vicinity of the gastric artery and was judged that the coil tail could to be pushed into the gastric artery using a snare and the procedure was completed.The coil separated 3 times during the procedure.The procedure was completed without further issues.However, due to the event it was delayed by 100 minutes.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.The product is not available for the investigation.No further information is available.
Additional Manufacturer Narrative
This is follow-up mdr report being submitted with associated mfr# 2954740-2017-00095.
Additional Manufacturer Narrative
This is final mdr report being submitted with associated mfr# 2954740-2017-00095.The deltamaxx coil was not returned for investigation.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Resistance / friction, unraveled / stretched and separated are all well-known potential product malfunctions associated with the use of the codman embolic coils, and the ifu has warning and precautions listed for these potential events.Surgical delay, while not specifically listed in the ifu, is a known potential event that is associated with all invasive procedures when product malfunctions occur.The severity of a surgical delay is dependent upon several factors including age of the patient, patient comorbidities, nature of the invasive procedure and maintenance of anesthesia during the delay.In an abundance of caution, codman captures all surgical delays greater than 30 minutes as reportable adverse events.Review of the available information suggests that the reported product malfunctions contributed in a cascading manner to the surgical delay.No further actions are required at this time.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6553599
• Report Number: 2954740-2017-00095
• Device Sequence Number: 627508
• Product Code: HCG
• UDI-Device Identifier: 10878528008573
• UDI-Public: (01)10878528008573(17)211031(10)S12585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CDX18062530
• Device Lot Number: S12585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/23/2017; 06/14/2017
• Patient Sequence Number: 1
• Patient Age: 77 YR