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

Catalog Number	4006C0408
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using penumbra coil 400s (pc400s).During the procedure, the physician placed a coil in the target vessel using a lantern delivery microcatheter (lantern).The physician then experienced resistance while advancing a pc400 in the middle of the lantern; therefore, the pc400 was removed.It was reported that the pc400 ¿stretched¿ while being removed.The procedure was then completed using the same lantern, five pc400s and one other coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 142.0, 145.0 and 149.0 cm from the proximal end.The proximal constraint sphere was intact with the pusher assembly distal detachment tip (ddt).The distal titanium sphere of the embolization coil was within the proximal end of the coil.The embolization coil was stretched.Conclusions: evaluation of the returned pc400 confirmed that the embolization coil was unraveled.Further evaluation revealed the distal sphere pulled out of distal pet component which likely contributed to the embolization coil stretching as reported in the complaint.This damage typically occurs when the device is forcefully retracted against resistance.The sr wire was intact.The root cause of the distal sphere pulling out of the pet component could not be determined.Penumbra coils 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8707301
• Report Number: 3005168196-2019-01179
• Device Sequence Number: 2072908
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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,Followup
• Report Date (Section B): 05/20/2019
• 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: 07/18/2026
• Device Catalogue Number: 4006C0408
• Device Lot Number: F84759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005