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

Model Number	4002C1245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
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 splenic artery using penumbra coils 400 (pc400).During the procedure, the physician successfully placed three pc400s using a non-penumbra microcatheter.The physician was then unable to advance another pc400 through the hub of the microcatheter; therefore, the pc400 was removed and the procedure was completed using new pc400s and additional coils with the same microcatheter.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 pusher assembly.The pusher had a bend approximately 62.5 cm from the proximal end.The pc400 assembly was intact.The embolization coil had offset coil winds near the proximal end of the coil.The pc400 was able to advance through a demonstration microcatheter with minor resistance.Conclusion: evaluation of the returned pc400 revealed a device with offset coil winds.If the introducer sheath is not aligned properly in the hub of the parent device, resistance may be experienced.If the device is forcefully advanced while experiencing resistance, damage such as offset coil winds may occur.Based on the return condition, the bend is likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02:3005168196-2018-02311.Expiration date.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8100111
• Report Number: 3005168196-2018-02311
• Device Sequence Number: 11243531
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• 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,Followup
• Report Date (Section B): 10/25/2018
• 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: 11/14/2025
• Device Model Number: 4002C1245
• Device Catalogue Number: 4002C1245
• Device Lot Number: F80572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/04/2019; 01/14/2005
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 03/06/2019; 01/31/2020
• 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