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

Catalog Number	RBYPODJ60
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
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.This report is associated with mfr report numbers: 3005168196-2019-02136; 3005168196-2019-02138; 3005168196-2019-02139.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podjs) and a ruby coil.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician placed a pod6 in the target vessel using a non-penumbra microcatheter.Next, the physician attempted to advance a podj (f84471); however, the coil would not advance through the microcatheter; therefore, the podj was removed.The physician then attempted to advance two new podjs (f84743 and f91605) and a ruby coil (f80309); however, the same issue occurred, and the coils would not advance through the microcatheter.Therefore, the podjs and ruby coil were removed.The procedure was then completed using a non-penumbra embolic agent in order to not lose access to the tortuous vessel.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the device.The pusher assembly was twisted and kinked approximately 42.5cm from the proximal end.The proximal constraint sphere was attached to the pusher assembly, however the embolization coil was broken and not returned for evaluation.Conclusions: evaluation of the returned first pod packing coil, the third pod packing coil and the ruby coil revealed offset coil winds on all three embolization coils.If the introducer sheath is not properly aligned with the hub of the microcatheter, or the coil is advanced against resistance, damage such as offset coil winds may occur.Offset coil winds may then contribute to additional resistance.The second pod packing coil was unable to be functionally tested due to the returned damages.In addition, the embolization coil was not returned for evaluation.Therefore, the reported complaint could not be confirmed, and potential cause 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the resistance experienced during the procedure.This report is associated with mfr report numbers: 3005168196-2019-02136 3005168196-2019-02138 3005168196-2019-02139.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9328589
• Report Number: 3005168196-2019-02137
• Device Sequence Number: 19486873
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 10/22/2019
• 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: 07/17/2026
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F84743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005