MAUDE Adverse Event Report: PENUMBRA, INC. POD5; HCG, KRD

Device Problems Positioning Failure (1158); Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

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.This report is associated with mfr report number: 3005168196-2015-01194.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod5 coils and ruby coils.During the procedure, the physician attempted to deploy a pod5 coil into the aneurysm; however, the pod5 coil would not coil up and was removed and resheathed.The physician then successfully deployed and detached a pod4 coil into the aneurysm.Another attempt was made to deploy the previous pod5 coil but was again unsuccessful because the coil would not coil up in the aneurysm and was removed.The physician then decided to deliver a new ruby coil; however, the ruby coil became rigid and was difficult to advance through the px slim delivery microcatheter (px slim).While attempting to remove the ruby coil from the px slim, the ruby coil unintentionally detached.The physician tried using a large syringe to aspirate the ruby coil out and also flushed it with saline but was unable to remove the coil.Lastly, the physician tried using a wire to push the ruby coil out but was also unsuccessful.The physician then removed the px slim containing the ruby coil and continued the procedure using another manufacturer's coils and a new microcatheter.

• Brand Name: POD5
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5243738
• MDR Text Key: 31978512
• Report Number: 3005168196-2015-01195
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR