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

Catalog Number	RBYPODJ15
Medical Device Problem Codes	Unraveled Material (1664); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
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 number: 3005168196-2017-01108.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a collateral vessel using pod packing coils (podj's).During the procedure, prior to use, the hospital technician was unable to advance a podj out of its introducer sheath on the scrub table.Therefore, the podj was set aside and a new podj was opened.After advancing the new podj in the target vessel using a lantern delivery microcatheter (lantern), the hospital technician was not satisfied with the coil position and decided to retract and pull the podj out of the patient.While attempting to retract the podj, the hospital technician did not mention resistance; however, the podj unraveled.The hospital technician was able to remove the podj from the patient without any issues and the procedure was ended at this point.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: 6690013
• Report Number: 3005168196-2017-01109
• Device Sequence Number: 16161187
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/07/2017

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: Other Health Care Professional
• Device Expiration Date: 10/22/2024
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F72459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR