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

Model Number 104-4310

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.As the device was not returned, we are unable to perform further root cause analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during an angioplasty procedure, the balloon ruptured.Several attempts to perform balloon angioplasty.No vessel injury was reported to have occurred and no recanalization was achieved.

Manufacturer Narrative

All balloons are 100% leak tested and all products are 100% inspected for damages and irregularities during manufacture.Occlusion balloon system instructions for use (ifu): ¿contraindications: not intended for embolectomy and angioplasty procedures.Do not exceed the maximum recommended inflation volume as balloon rupture may occur.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the angioplasty procedure, the hyperglide ruptured during its use.Selective catheterization of the left vertebral artery and left carotid artery using a bern 5f.Replacement procedure and introduction of a catheter neuron max in the left internal carotid artery.Coaxial introduction of a catheter sofia 5f, a microcatheter echelon 10 and a micro-guidewire synchro 14.Multiple attempts to perform catheterization of the occluded left temporal branch.Several attempts to perform balloon angioplasty (balloon hyperglide 4-10 and scepter c 4-10) of the artisse device.No recanalization.Control arteriography after the procedure.Brain scan after the procedure.Removal of the desilet catheter introducer and manual compression of the left femoral artery for approximately 15 minutes.The synchro 14 was used with the hyperglide.The guidewire was discarded.The guidewire tip was shaped by the user.The middle section of the balloon was ruptured.Contrast solution used was visipaque 320 50/50.The balloon was reported to have ruptured on the first inflation.The injection was done slowly.A 1ml luerlock syringe was used.The anatomy was normal and not tortuous.The information was provide by dr desilles.Qc (limpeh1, 28mrt2018);.

• Brand Name: HYPERGLIDE
• 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 ; 9492753836
• MDR Report Key: 7268531
• MDR Text Key: 100146657
• Report Number: 2029214-2018-00107
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021066
• 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,Followup
• Report Date: 04/18/2018

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: 06/01/2019
• Device Model Number: 104-4310
• Device Catalogue Number: 104-4310
• Device Lot Number: A361819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2016
• 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: 67 YR