MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE068

Device Problems Break (1069); Material Separation (1562); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that the following device code also applies to this complaint: (b)(4).The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

While a penumbra system 3max reperfusion catheter (3maxc) was being prepared for a thrombectomy procedure, it "came apart" in the physician''s hands.The 3maxc became damaged prior to use and therefore, was not used during the procedure.The procedure was completed using another catheter.

Manufacturer Narrative

Please note that additional clarification was received indicating that the device in complaint was a penumbra system ace68 reperfusion catheter (ace68) and not a penumbra system 3max reperfusion catheter (3maxc).Therefore, any mention of the 3maxc on the initial mfr report should be updated to the ace68.Results: the ace68 was fractured approximately 91.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that it was fractured.This damage may have occurred due to forceful manipulation of the ace68 during preparation for use or insertion into a parent catheter.Penumbra catheters 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

While a penumbra system ace 68 reperfusion catheter (ace68) was being prepared for a thrombectomy procedure, it "came apart" in the physician's hands.The ace68 became damaged prior to use and therefore, was not used during the procedure.The procedure was completed using another catheter.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 7208022
• MDR Text Key: 98071737
• Report Number: 3005168196-2018-00188
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/10/2020
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F79452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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