MAUDE Adverse Event Report: PENUMBRA, INC. POD 4; HCG, KRD

Catalog Number	RBYPOD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The embolization coil was detached from its pusher assembly.The pull wire remained inside the distal detachment tip (ddt) capture feature.Conclusions: evaluation of the returned pod4 confirmed that the embolization coil was detached from its pusher assembly.Further evaluation of the returned pod4 revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire remained intact within the ddt.If the pod4 is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire within the ddt, which will allow the embolization coil to detached from its pusher assembly.No other devices associated with the complaint were returned for evaluation.Therefore, the root cause of resistance could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod4s.During the procedure, the physician was repositioning a pod4 in the target vessel and reported that it unintentionally detached.The pod4 was able to be implanted; however, the physician would have preferred it more distal in the target vessel.The physician was content with the result; therefore, no additional coils were implanted.There was no report of an adverse effect to the patient.

• Brand Name: POD 4
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9403714
• Report Number: 3005168196-2019-02172
• Device Sequence Number: 16951849
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• 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
• Report Date (Section B): 10/11/2019
• 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: 06/11/2025
• Device Catalogue Number: RBYPOD4
• Device Lot Number: C12248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• 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: 10/11/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Date Report Sent to FDA: 01/01/2005