MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXTRASOFT COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100204
Medical Device Problem Codes	Stretched (1601); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00266.Additional procodes: krd/hcg.(b)(4).The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a deltaxsft coil (dlx100204/s11999) was stretched in the coil mass during a procedure.The deltaxsft coil (complaint product) was smoothly advanced into an aneurysm and then retracted back into the microcatheter.When the physician re-advanced it a lot of resistance was felt.The physician tried to pull it back into the microcatheter and also had resistance as the microcatheter had ¿locked up¿.The coil was stuck in the coil mass.The doctor ended up cutting the coil pusher and sheath, the microcatheter in an attempt to snare it.The snare would not advance.He then held distal end of the wire and tried pushing the microcatheter back over the coil.At this time, it easily advanced and the physician was able to pull the coil out; the coil was stretched.The physician was able to finish the case with no patient complications.
Additional Manufacturer Narrative
The device was returned in pieces.Part of an unnamed microcatheter was returned.There is a length of blue-colored tubing that is not a part of the embolic coil device or the microcatheter.The dpu core wire is cut approximately 23 cm from the proximal end.The embolic coil is stretched and tangled around the 2 pieces of dpu.The ball tip end of the embolic coil is present and stretched.The entire length of the embolic coil is stretched, kinked, and tangled.The articulating joint is damaged.There is small fracture at the point of the v-notch and damage to its sides.The translucent introducer sheath is kinked where it exits the resheathing tool.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 nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Conclusion: the complaint that the embolic coil is stretched is confirmed.The complaint of resistance to advancement cannot be confirmed because of the damage to the embolic coil.The damage to the dpu and the unnamed microcatheter and blue tubing are reported by the healthcare professional as part of the event.The physician cut the devices in an attempt to retrieve the embolic coil, which was reported as being stuck in the coil mass.The amount of stretching damage to the embolic coil is consistent with the report of the physician¿s efforts to retrieve the embolic coil from the patient.If the end of the coil was trapped in the coil mass, then it is likely that the coil would stretch during a forceful attempt to retrieve it.Damage to the v-notch indicates that the user did not unlock the translucent introducer sheath according to the ifu instructions (see (b)(4)), but appears to be unrelated to the complaint.As there were no related issues in the manufacturing or inspection processes and there is no current safety signal for the device or the complaint no further action will be taken at this time.

• Brand Name: DELTAXTRASOFT COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6883672
• Report Number: 2954740-2017-00266
• Device Sequence Number: 1142174
• Product Code: KRD
• UDI-Device Identifier: 10886704077329
• UDI-Public: (01)10886704077329(17)190831(10)S11999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: DLX100204
• Device Lot Number: S11999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 10/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention