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

Catalog Number	DLX100254
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: krd/hcg.Concomitant: a sheath introducer (6f), a guide wire (chikai14, chikai 14 black , asahi intecc ) , a guiding catheter (6f roadmaster, goodman), a micro catheter (headway 17, terumo), a balloon catheter (scepter c) and an enpower were also used for this procedure.(b)(6).The device was not available for analysis.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.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an unruptured aneurysm, there was resistance between a deltaxtrasoft (dlx100254, s11984) and a headway 17 microcatheter, and during coil resheathing, the sheath introducer was damaged and the coil could not be re-sheathed.The micro catheter was approached to the lesion as steam-shaped.¿the only inflow got clogged tightly when the coils (micrusframes5x17, micruframec4x8, deltaxsft3x6, deltaxsft3x6, deltaxsft2.5x4) was inserted¿ , so the physician tried to re-sheath the deltaxtrasoft (complaint product), but the sheath introducer got damaged and could not be re-sheathed.After that, the micro catheter was reinserted, and the coil was replaced with another one (same size) and additional 6 coils were placed in the lesion.The procedure was successfully completed without further issues or delay.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.The product was not available for the investigation.No further information was available.
Additional Manufacturer Narrative
As reported by a healthcare professional, during coil embolization of an unruptured aneurysm, there was resistance between a deltaxsft (dlx100254, s11984) and a headway 17 microcatheter, and during coil resheathing, the sheath introducer was damaged and the coil could not be re-sheathed.The microcatheter was approached to the lesion as steam-shaped.¿the only inflow got clogged tightly when the coils (micrusframes5x17, micruframec4x8, deltaxsft3x6, deltaxsft 3x6, deltaxsft 2.5x4) was inserted¿, so the physician tried to re-sheath the deltaxsft (complaint product), but the sheath introducer got damaged and could not be re-sheathed.After that, the microcatheter was reinserted, and the coil was replaced with another one (same size) and additional 6 coils were placed in the lesion.The procedure was successfully completed without further issues or delay.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.The product was not available for the investigation.Multiple attempts to obtain additional information were unsuccessful.The deltaxsft product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The resistance between the deltaxsft and the non-codman microcatheter and the re-sheathing issue could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, the concomitant microcatheter or procedural/handling factors may have contributed to the event.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions 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: 6869446
• Report Number: 2954740-2017-00263
• Device Sequence Number: 788203
• Product Code: HCG
• UDI-Device Identifier: 10886704077275
• UDI-Public: (01)10886704077275(17)190831(10)S11984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: DLX100254
• Device Lot Number: S11984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/09/2017
• Patient Sequence Number: 1