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

Model Number RBYPOD10-A

Device Problems Failure to Fold (1255); Retraction Problem (1536); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization in the splenic artery to treat an aneurysm using pod10s and a non-penumbra microcatheter.During the procedure, the physician advanced the pod10 to the target vessel using the microcatheter.After forming a loop with the pod10, the physician decided to rewind it as the pod10 was not taking good shape in the aneurysm.However, the pod10 became stuck, and the pod10 in unintentionally detached in the microcatheter; subsequently, the microcatheter containing the detached pod10 was removed, and the pod10 was flushed out.The procedure was completed using another pod10, other coils, and the same microcatheter.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization in the splenic artery to treat an aneurysm using pod10s and a non-penumbra microcatheter.During the procedure, the physician advanced the pod10 to the target vessel using the microcatheter.After forming a loop with the pod10, the physician decided to rewind it as the pod10 was not taking good shape in the aneurysm.However, the pod10 became stuck, and the pod10 unintentionally detached in the microcatheter; subsequently, the microcatheter containing the detached pod10 was removed, and the pod10 was flushed out.The procedure was completed using another pod10, other coils, and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: (b)(4) 1.Section b.Box 5.Describe event or problem.Results: the pet lock was separated on the proximal end of the pusher assembly and the pull tube was retracted.Kinks were present throughout the length of the pusher assembly.The pull wire was not within the pusher assembly distal detachment tip (ddt) conclusions: evaluation of the returned pod10 revealed that pet lock was separated on the proximal end of the pusher assembly.If the pusher assembly is mishandled during use, the pet lock can become inadvertently separated.If the pet lock is separated and the pull wire is retracted, the embolization coil will detach.Further evaluation revealed kinks throughout the length of the pusher assembly.These kinks were likely incidental to the reported complaint.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.H3 other text : placeholder.

• Brand Name: POD
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9826281
• MDR Text Key: 188524112
• Report Number: 3005168196-2020-00346
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 00814548019659
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPOD10-A
• Device Catalogue Number: RBYPOD10
• Device Lot Number: F85915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR