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

Catalog Number	4002C1450
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
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 using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then attempted to advance a pc400, however felt resistance that became stronger the more the pc400 was advanced.The physician eventually was unable to advance the pc400 out of its introducer sheath and into the microcatheter, and therefore, the pc400 was removed.The procedure was then completed using four additional pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: he pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The embolization coil winds were offset inside the introducer sheath and introducer sheath had coagulated blood was observed inside.Conclusions: evaluation of the returned device revealed that the embolization coil winds were offset inside the introducer sheath and the sheath had coagulated blood inside.This type of damage typically occurs due to improper handling during use.If blood enters the introducer sheath and began to coagulate along the embolization coil prior to advancement, upon attempting to advance the coil out of its introducer sheath resistance may be encountered and, damage such as offset coil winds may occur.The offset coil winds and coagulated blood inside the introducer sheath likely contributed to the resistance experienced and prevented the coil from being advanced into the non-penumbra microcatheter.While attempting to advance the pc400 through a demonstration microcatheter; resistance was encountered and the pc400 could not be advanced out of its introducer sheath.The non-penumbra microcatheter mentioned in the complaint was not returned 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7165922
• Report Number: 3005168196-2018-00039
• Device Sequence Number: 13906480
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2017
• 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: Physician
• Device Expiration Date: 10/30/2024
• Device Catalogue Number: 4002C1450
• Device Lot Number: F72600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 12/12/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/12/2018; 12/28/2018
• 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