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

Catalog Number	RBYPOD4
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using pod4s.During the procedure, while attempting to advance the pod4 through a non-penumbra microcatheter, the physician encountered resistance; therefore, the physician removed the pod4 and flushed the microcatheter.The pod4 was then re-advanced into the same microcatheter; however, the physician encountered resistance around the same area, and therefore, the pod4 was removed.The procedure was completed using another pod4, twelve other coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly had bends approximately 22.5, 55.0 and 88.5 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Coagulated blood was found within the introducer sheath.Conclusions: evaluation of the returned pod4 revealed dried blood within the introducer sheath.Due to the dried blood, resistance was experienced during manipulation of the pod4 within its introducer sheath during functional testing.Consequently, the embolization coil became detached from the pusher assembly.No further testing was performed.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.The root cause of the reported 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 4
• Common Device Name: HCG,KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8965630
• Report Number: 3005168196-2019-01687
• Device Sequence Number: 2042382
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019
• 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: 04/11/2026
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F82810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005