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

Catalog Number	RBYPODJ45
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Kinks were present along the length of the pusher assembly.The stretch resistant (sr) wire was fractured and the embolization coil was unraveled.Conclusions: evaluation of the returned podj revealed that the embolization coil was detached and unraveled due to a fracture of the sr wire.The complaint indicated that resistance was encountered while retracting the podj through the lantern.If the podj is forcefully retracted against resistance, the sr wire may become fractured, and the embolization coil may become unraveled.The lantern used in the procedure was not returned for evaluation; therefore, the root cause of the reported resistance was unable to determined.Further investigation revealed that the pusher assembly had kinks along its length.These kinks were likely incidental to the complaint.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.This report is associated with mfr report number: 3005168196-2019-01852.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal mammary arteries (rima) using a pod packing coils (podj) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the podj into the target vessel using the lantern; however, the podj was not packing as expected and the physician decided to remove it.While retracting the podj through the lantern, the physician encountered resistance, and the podj began to unravel.The physician then pulled the podj and it continued to unravel until it was completely removed.The procedure was completed using embolization particles.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: 9152008
• Report Number: 3005168196-2019-01853
• Device Sequence Number: 3185925
• Product Code: HCG
• UDI-Device Identifier: 00814548016726
• UDI-Public: 00814548016726
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 09/05/2019
• 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: 03/29/2024
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F68737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Date Report Sent to FDA: 01/01/2005