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

Catalog Number	4004C0820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
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 varicocele coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed two ruby coils using a non-penumbra microcatheter.The physician then attempted to insert a pc400 into the microcatheter, however, the physician noticed that the pusher assembly of the pc400 was fractured 20cm from the proximal end, despite there being no resistance while advancing.Therefore, the pc400 was removed, and the procedure was completed using a new pc400 and 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 assembly was kinked approximately 5.0 and 22.5 cm from the proximal end.The pusher assembly was fractured approximately 26.5 cm from the proximal end.The embolization coil was detached from its pusher assembly.Conclusion: evaluation of the returned pc400 revealed that the pusher assembly was fractured.If the device is forcefully handled at extreme angles during removal from the packaging or during preparation prior to use, damage such as fracture may occur.Further evaluation of the returned pc400 revealed that the embolization coil was detached from its pusher assembly.If the pusher assembly becomes fractured it may allow, the pull wire to retract out of the ddt and allow the embolization coil to detach from its pusher assembly.The non-penumbra microcatheter identified in the complaint and the pc400 embolization coil were 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8544850
• Report Number: 3005168196-2019-00773
• Device Sequence Number: 19443796
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019
• 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: 01/17/2026
• Device Catalogue Number: 4004C0820
• Device Lot Number: F81534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Date Report Sent to FDA: 01/01/2005