MAUDE Adverse Event Report: PENUMBRA, INC. POD4; HCG, KRD

Catalog Number RBYPOD4

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pod4 embolization coil was detached from its pusher assembly intact.The diameter of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the returned pod4 confirmed that the embolization coil was detached from its pusher assembly.The complaint cited that no resistance was experienced during advancement or retraction of the coil and that the subject lantern had no visible damage.The pusher assembly and lantern identified in the complaint were not returned for evaluation.Therefore, the root cause of the reported failure could not be determined.Penumbra coils and catheters 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 Description

The patient was undergoing a coil embolization procedure in the splenic artery using a pod4.During the procedure, while attempting to place a pod4 into the target vessel using a lantern delivery microcatheter (lantern), the tip of the pod4 hit the wall of the vessel several times and the pod4 kicked back very hardly.The physician could not control the pod4 in the aneurysm and decided to remove it; however, while removing the pod4 from the lantern, the pod4 unintentionally detached inside the lantern.Therefore, the physician removed the guiding sheath and the lantern containing the detached coil.The procedure was completed using another microcatheter and other coils.There was no noted damage to the lantern after removal.There was no report of an adverse effect to the patient.

• Brand Name: POD4
• 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: 7543057
• MDR Text Key: 109235365
• Report Number: 3005168196-2018-01047
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013756
• UDI-Public: 00814548013756
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPOD4
• Device Lot Number: F75466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• 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: 61 YR