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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Entrapment of Device (1212); Inadequacy of Device Shape and/or Size (1583); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2017-00522, 3005168196-2017-00523.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypo gastric artery using pod packing coils (podj coils) and ruby coils.During the procedure, the physician advanced a podj in the target vessel using a lantern delivery microcatheter (lantern); however, the podj coil was too long for the aneurysm and therefore, the physician decided to remove it.While removing the lantern and the podj coil altogether, part of the podj coil was out of the tip of the lantern and got caught with the base catheter; subsequently the podj stretched after removal.The lantern was then flushed and re-inserted into the patient¿s body.While using a ruby coil with the lantern, the physician lost access to the target vessel and decided to remove the lantern and the ruby coil altogether.However, while retracting the lantern, part of the ruby coil was out of the tip of the lantern and got caught with the base catheter and subsequently, the ruby coil became stretched after removal.Next, the physician flushed the lantern and re-inserted it into the patient¿s body.While using a new ruby coil with the lantern, the physician loss access in the target vessel again and decided to withdraw the ruby coil; however, while retracting the ruby coil, the physician pulled the ruby coil at an angle and the ruby coil pusher assembly became bent.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6455074
• Report Number: 3005168196-2017-00521
• Device Sequence Number: 621948
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: 12/26/2023
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F67090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 98