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

Catalog Number DLX100153

Device Problems Kinked (1339); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Mfg name: codman & shurtleff, inc.Dba depuy synthes products, inc.This event met mdr reporting when the analysis revealed coil stretching and kink.Conclusion: the distal end of the embolic coil is located in the green introducer.The dpu has protruded from the skive of the translucent introducer sheath.There is a severe kink in the dpu core wire at the strain relief.The ball tip is intact.The embolic coil is stretched and kinked.The articulating joint is damaged.There is damage to the translucent introducer sheath near the point of protrusion.Microscopic image of the dpu protruding from the skive of the translucent introducer sheath.There is some damage to the sides of the v-notch on the resheathing tool.Advancement through a microcatheter cannot be tested because the cpu has protruded from the translucent introducer sheath.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device was impeded in the microcatheter cannot be confirmed.Almost the entire length of the dpu has protruded from the skive of the translucent introducer sheath.Damage to the embolic coil and articulating joint suggests that excessive force was applied to the device, possibly in an attempt to overcome resistance.In addition, the damage observed on the translucent introducer sheath may be due to overtightening of the rhv.The ifu cautions against overtightening the rhv, as excessive pressure may damage the introducer or the embolic coil.While the exact sequence of events is unknown, the end user may have overtightened the rhv, damaging the embolic coil and the translucent introducer sheath, and hindering advancement through the microcatheter.The damage to the translucent introducer sheath, along with excessive force applied in an attempt to overcome resistance, may have caused the dpu to protrude from the translucent introducer.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.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization of the inferior petrosal sinus, a deltaxsft10 1.5mm x 3cm coil (dlx100153/s13174) was impeded in the sl-10 microcatheter.The first and second coil (target, stryker) were used then the deltaxsft10 1.5mm x 3cm was opened for the third coil.The coil was advanced to the reverse-t, but the coil did not come out from the distal of the microcatheter.The coil was replaced with another one (same size) in case of suspicious of unraveled coil, and was advanced.Even though the 2nd marker of the microcatheter was hidden just by the distal marker of the guiding catheter (fubuki) and could not be align the position of markers, the coil was detached successfully and the procedure was completed.After the procedure, there was possibility that the microcatheter had stretched because the catheter was considerably overworked, but it was unclear.No unraveled coil was observed visually.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.It was reported that the product would be returned for investigation.No further information was available.

• Brand Name: DELTAXTRASOFT COIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6964154
• MDR Text Key: 90674669
• Report Number: 3013875781-2017-00012
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077268
• UDI-Public: (01)10886704077268(17)191231(10)S13174
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• 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
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: DLX100153
• Device Lot Number: S13174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1