MAUDE Adverse Event Report: DELTAPLUSH COIL, 10 SYS 2X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DPL100206-20
Medical Device Problem Codes	Kinked (1339); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00509.Procode: krd/hcg.Concomitant medical products: deltapaq 2x6 coil, micrusphere 2 mm x 2.5 cm coil, micrusphere 10 3.5 mm x 6.6 cm coil, envoy guide catheter.Conclusion: the complaint that the device was impeded in the microcatheter cannot be confirmed.Because the embolic coil is severely stretched, it cannot be retracted into the introducer in order to test advancement through a microcatheter.However, the damage to the embolic coil can be anticipated to prevent advancement.Since the exact sequence of events is unknown, the cause of the damage to the embolic coil cannot be determined.The stretched and kinked embolic coil, damaged articulating joint, and bends in the dpu are all evidence of the application of excessive force to the device, possibly in an attempt to overcome resistance.Resistance could have been a result of insufficient flush.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.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 non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
It was reported by a healthcare professional that a deltaplush coil (dpl10020620/p10799) experienced resistance in the microcatheter and could not be used during a re-treatment of a basilar apex aneurysm procedure, previously stented/coiled (only 1 coil used on first treatment axium 4 mm coil).Reportedly, one coil was in and the second coil came out of the stent strut.The coil was removed and the physician decided to let stent heal for few months then bring the patient back and treat.The patient¿s vessel was moderately tortuous.A 6fr.Sheath rt.Was advanced through the femoral artery, a 6fr envoy guide to lt.Vertebral artery, and an echelon 10 microcatheter and xpedion 014¿ guidewire were advanced to the aneurysm through the stent strut.Two micrusphere 10 3.5 mm x 6.6 cm coils were delivered and detached, followed by two micrusphere 2 mm x 2.5 cm coils that was delivered and detached.A deltaplush 2x6 coil (complaint product) was the next coil opened.An attempt was made to load the deltaplush into the microcatheter, however, the scrub tech stated that the coil was not advancing easily and the physician removed the coil from the microcatheter.The physician said the coil is soft and folds on itself.A deltapaq 2x6 was used advanced without problem and detached into aneurysm.The final coil used to successfully complete the procedure was a deltapaq 1.5x6.There was no medical intervention required to the patient as a result of this event.The physician was pleased with the outcome of the procedure.The patient was doing well post procedure and was discharged from the hospital on (b)(6) 2017.This complaint was deemed reportable based on the device investigation results.

• Brand Name: DELTAPLUSH COIL, 10 SYS 2X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7201805
• Report Number: 3008114965-2018-00509
• Device Sequence Number: 10996187
• Product Code: KRD
• UDI-Device Identifier: 00878528008071
• UDI-Public: (01)00878528008071(17)200630(10)P10799
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142429
• 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
• Report Date (Section B): 10/31/2017

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 Model Number: DPL100206-20
• Device Catalogue Number: DPL10020620
• Device Lot Number: P10799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 104