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

Catalog Number	4004C1030
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
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 subclavian artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed three coils using a non-penumbra microcatheter.The physician then felt resistance while advancing a pc400 within its introducer sheath and, therefore, the pc400 was removed.The procedure was then completed using new pc400s and a pod packing 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 its pusher assembly.The pusher assembly was kinked approximately 43.0, 56.0 and 80.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.The introducer sheath had coagulated blood inside the lumen.During functional analysis, the pc400 was able to advance through its introducer sheath and resistance was encountered while attempting to advance the pc400 pusher assembly kinks into the introducer sheath.The pc400 was then able to be advanced through a demonstration microcatheter with resistance as the kinks in the pusher assembly were advanced through the introducer sheath and the demonstration microcatheter.Conclusions: evaluation of the returned pc400 revealed that the embolization coil had offset winds and the pusher assembly had kinks.If the device is forcefully manipulated against resistance, damage such as offset coil winds and kinks may occur.The non-penumbra microcatheter identified in the complaint was not returned for evaluation and, therefore, the root cause of resistance could not be determined.Further evaluation of the returned pc400 revealed that the pusher assembly was kinked, and the introducer sheath had coagulated blood inside.Some of the kinks were likely incidental to the reported complaint.The coagulated blood within the introducer sheath likely contributed to resistance experienced during the functional test.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8744442
• Report Number: 3005168196-2019-01272
• Device Sequence Number: 1490140
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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): 05/30/2019
• 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: 07/15/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F78197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005