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

Catalog Number	RBYPODJ60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 splenic artery using a pod packing coil (podj) and a lantern delivery microcatheter (lantern).It was reported that the patient anatomy was tortuous.During the procedure, the physician advanced a podj into the target vessel using the lantern and needed to reposition the podj.While repositioning the podj, it unintentionally detached inside the lantern; therefore, the lantern containing the detached podj was removed and the podj was flushed out.The procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the stretch resistance wire (sr wire) was fractured and offset coil winds were present throughout the length of the embolization coil.The proximal constraint sphere was not present on the proximal end of the embolization coil.Conclusions: evaluation of the returned podj revealed a sr wire fracture.If the device is forcefully retracted against resistance, damage such as a sr wire fracture may occur.If this occurs, the embolization coil will detach from the pusher assembly.The podj pusher assembly and the lantern identified in the complaint were not returned for evaluation; therefore, the root cause of the resistance could not be determined.Penumbra coils are 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: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9861820
• Report Number: 3005168196-2020-00419
• Device Sequence Number: 2874813
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020
• 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 Catalogue Number: RBYPODJ60
• Device Lot Number: F93544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005