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

Catalog Number 400SMTSFT0406

Device Problems Unsealed Device Packaging (1444); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the product display box was missing a peelable label.The sterile product pouch was opened from the corner and was missing two peelable labels.The third sterile pouch peelable label was removed by the penumbra investigator.The packaging hoop can be seen upside down inside the open product pouch.Conclusions: evaluation of the returned device revealed that the sterile product pouch was open and the smart coil was likely manipulated by outside influence.Approximately 50% of the sterile pouch cover had been peeled away, the proximal end of the pusher assembly was kinked, several peelable labels were missing, and the packaging hoop was inside the product pouch upside down.This sterile barrier of damage is likely the result of the pouch being opened from the corner as designed.The extent to which the package was opened was unlikely to happen without outside influence.The kink is likely a result of a forcefully gripping in an attempt to unseat the proximal pusher assembly from the retainer clip.The peelable labels missing suggest they were removed during preparation to document the expected use of the device.The packaging hoop existing upside down inside the sterile product pouch suggests that the hoop was removed from the pouch and later reinserted.The root cause of this failure 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.

Event Description

During preparation for a coil embolization procedure, the hospital staff noticed that the sterile pouch containing a new penumbra smart coil (smart coil) was not sealed upon opening the packaging box.The unsealed sterile package was found prior to use and therefore, the smart coil was not used in the procedure.The procedure was completed using another smart coil.

• Brand Name: PENUMBRA SMART COIL
• 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: 6546191
• MDR Text Key: 74480723
• Report Number: 3005168196-2017-00698
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015071
• UDI-Public: 00814548015071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2020
• Device Catalogue Number: 400SMTSFT0406
• Device Lot Number: F66234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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