MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0610
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked in multiple locations and fractured approximately 12.0 cm from the proximal end.The pull tube was completely withdrawn out of the pusher assembly hypotube.The embolization coil was detached from the pusher assembly, the distal end of the pull wire was retracted proximal to the distal detachment tip (ddt), and dried blood was observed in within the ddt.Conclusions: evaluation of the returned devices revealed the pusher assembly was kinked and fractured.The kinks likely occurred due to forceful manipulation during navigation of patient anatomy.The fracture likely occurred during attempts to manually detach the pc400.Further evaluation revealed the embolization coil was detached.Pusher assembly kinks, dried blood within the pusher assembly, and tortuous patient anatomy can cause a build-up of friction between the pull wire and the hypotube, overcoming the pull force that a handle is able to apply.Withdrawing or repositioning the pc400 may alleviate some of the friction, and subsequently allow the embolization coil to detach.The handle had no visible damage and functioned as intended during testing.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a undergoing a coil embolization procedure in the splenic artery using penumbra coils 400 (pc400¿s).It was noted that the patient¿s anatomy was moderately tortuous and slightly calcified.During the procedure, the physician placed a pc400 and three non-penumbra coils in the target vessel using a lantern delivery microcatheter (lantern).The physician then advanced a new pc400 in the target and attempted to detach it using a penumbra coil 400 detachment handle (handle); however, the coil failed to detach.Therefore, the physician manually pulled the pull wire but the pc400 would not detach.The physician then pulled the lantern back a bit and manually pulled the pull wire again; however, the pc400 would still not detach.Subsequently, the physician attempted to retract the entire pc400 from the lantern; however, the pc400 unintentionally detached inside the lantern.Therefore, the physician removed the pc400 pusher assembly, then used another pusher wire to push the detached coil into the target vessel.The procedure was completed using the same lantern, a pod6, other coils and glue.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7321942
• Report Number: 3005168196-2018-00502
• Device Sequence Number: 1606099
• Product Code: HCG
• UDI-Device Identifier: 00814548010878
• UDI-Public: 00814548010878
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2018

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: Physician
• Device Expiration Date: 10/02/2018
• Device Catalogue Number: 4004C0610
• Device Lot Number: F38778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR