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

Catalog Number	4006C0408
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
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 internal iliac artery using penumbra coils 400s (pc400s).It was noted that the patient¿s anatomy was slightly tortuous and calcified.During the procedure, the physician placed two non-penumbra coils and one pc400 in the target vessel using a non-penumbra microcatheter.While retracting a new pc400 for repositioning, the coil unraveled; therefore, the physician decided to remove it.However, while withdrawing the pc400, it became elongated in the patient¿s body.The physician was able to remove most of the pc400 but suspected that a small amount of the elongated part of the pc400 broke and remained in the patient¿s body.Subsequently, thrombus formed and therefore, the physician used a non-penumbra catheter to remove the thrombus.The procedure was completed by pressing the suspected remaining piece of the coil to the vessel with a stent graft, preventing the coil from floating in the patient¿s body.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 28.0, 35.0, and 125.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and the proximal constraint sphere was inside the distal detachment tip (ddt).The embolization coil stretch resistant wire (sr wire) was fractured.Conclusion: evaluation of the returned pc400 revealed that the sr wire was fractured.This type of damage typically occurs due to forceful retraction of the device against resistance.The non-penumbra microcatheter was not returned to penumbra for evaluation.Therefore, the root cause of the resistance could not be determined.Further evaluation of the returned pc400 revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported issue and may have occurred while packaging the device for return to penumbra.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: 7716330
• Report Number: 3005168196-2018-01457
• Device Sequence Number: 11042902
• 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): 06/26/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F73922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005