MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	E2012-11
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.When the common carotid balloon was inflated with recommended volume of 1.5 ml of saline using a syringe, the balloon inflated properly.When we attempted to deflate the balloon using the same syringe, it initially deflated properly.However, after withdrawing almost 1 ml of saline from the balloon, the balloon stopped deflating.We observed that the balloon had covered the two inflation holes preventing the saline from entering into the skive holes.Internal carotid balloon inflated and deflated properly when it was inflated with 0.25 ml of saline.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.Our manufacturing team does conduct 100% inspection on each device and tests them for balloon functionality.Each balloon is inspected to ensure they inflate and deflate properly.It is possible that during manufacturing, the balloon was poorly assembled which led to this issue.Multiple inflations or over-inflation of the common carotid balloon at the hospital could have also contributed to this issue.Our engineering team has also addressed similar balloon deflation issues by improving the design of this product.The change involves the addition of inflation holes under the balloon and a change in the cut angle of the inflation arm, which will assist the balloons to inflate and deflate uniformly along their entire length.Device was not used in a patient.Procedure was completed using another shunt that they had in stock.
Event or Problem Description
During pre-use check, common carotid balloon failed to deflate completely.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8823219
• Report Number: 1220948-2019-00091
• Device Sequence Number: 2754872
• Product Code: MJN
• UDI-Device Identifier: 00840663101290
• UDI-Public: 00840663101290
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: E2012-11
• Device Lot Number: PFT3484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1