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

Catalog Number	4006C0204
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
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 major aortopulmonary collateral artery (mapca) using penumbra coil 400s (pc400).During the procedure, the physician successfully placed smart coils in the collateral circulation using a lantern delivery microcatheter (lantern).While advancing a new pc400, the physician experienced resistance approximately 20 centimeters into the microcatheter and, therefore, the coil was retracted.While retracting the pc400, it unintentionally detached at the hub of the microcatheter.Therefore, the lantern was removed containing the detached pc400.The procedure was completed using new pc400¿s 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 assembly was kinked approximately 10.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.The proximal constraint sphere was inside the distal detachment tip (ddt).Conclusions: evaluation of the returned pc400 revealed that the stretch resistant wire (sr wire) was fractured.If the device was forcefully retracted against resistance, damage such as an sr wire fracture may occur.The lantern identified in the complaint was not returned for evaluation; therefore, the root cause of the reported resistance was unable to be determined.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: 8549048
• Report Number: 3005168196-2019-00798
• Device Sequence Number: 361459
• Product Code: HCG
• UDI-Device Identifier: 00814548011783
• UDI-Public: 00814548011783
• 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): 03/26/2019
• 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: 07/18/2026
• Device Catalogue Number: 4006C0204
• Device Lot Number: F84756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 5
• Date Report Sent to FDA: 01/01/2005