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

Model Number RBYPOD6-A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (pod pc), pod coils and a non-penumbra microcatheter.During the procedure, while attempting to advance the pod packing coil into the microcatheter, the pod packing coil would not advance out of the introducer sheath.The physician attempted twice; however, the pod packing coil would not advance out of the introducer sheath.Therefore, the pod packing coil was removed, and a new pod packing coil was used.Next, the physician advanced the pod coil into the target vessel using the microcatheter; however, the pod coil would not form in the vessel.Subsequently, the physician decided to remove the pod coil.While retracting the pod coil from the target vessel, the pod coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the coil was flushed out.The procedure was completed using another pod coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14116008
• MDR Text Key: 289340695
• Report Number: 3005168196-2022-00168
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019611
• UDI-Public: 00814548019611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/14/2022

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
• Device Operator: Health Professional
• Device Model Number: RBYPOD6-A
• Device Catalogue Number: RBYPOD6
• Device Lot Number: F108252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female