MAUDE Adverse Event Report: COVIDIEN (IRVINE) HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4470

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The hyperform balloon will not be returned for evaluation as it was discarded; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization treatment of a cerebral aneurysm with flow diversion device, the hyperform balloon ruptured during the procedure.It was reported that during procedure, the physician used the hyperform balloon catheter after a flow diverter was placed.Percutaneous transluminal angioplasty (pta) was performed, then the balloon of the hyperform catheter ruptured.A new balloon catheter device was used to continue the procedure.The vessel was slightly severe in tortuosity and medium in size (diameter).No patient injury was reported.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7322333
• MDR Text Key: 101978366
• Report Number: 2029214-2018-00178
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 104-4470
• Device Lot Number: A445879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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