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

Catalog Number	4006C0306
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0, 19.0, and 38.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the pull wire was completely retracted out of its distal detachment tip (ddt).The proximal constraint sphere was intact with the embolization coil.The pc400 embolization coil was detached from its pusher assembly and, therefore, the pc400 could not be functionally tested.Conclusions: evaluation of the returned pc400 revealed that the pet lock was broken, the pull wire was completely retracted out of the pusher assembly and the embolization coil was detached from its pusher assembly.If the pet lock is broken and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.Further evaluation of the pc400 revealed that the pc400 pusher assembly was kinked.These kinks may have occurred due to forceful advancement against resistance as indicated in the complaint.Based on the returned condition of the device, the root cause of the reported resistance while advancing the pc400 inside the lantern could not be determined.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually 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 coil embolization procedure in the internal iliac artery using penumbra coils 400 (pc400s).During the procedure, the physician deployed and detached 8 pc400s in the target location using a lantern delivery microcatheter (lantern).While advancing a new pc400 through the lantern, the physician experienced resistance around 20 cm from the lantern proximal tip; therefore, the lantern containing the pc400 was removed from the patient.The physician then flushed and rinsed the pc400 and attempted to advance it again; however, the same issue occurred.The procedure was completed using two new pc400s and the same lantern.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: 7765158
• Report Number: 3005168196-2018-01528
• Device Sequence Number: 1757763
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2018
• Report Date (Section F): 01/01/2005

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: 11/26/2025
• Device Catalogue Number: 4006C0306
• Device Lot Number: F80708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 60
• Date Report Sent to FDA: 01/01/2005