MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number SPL12510WL

Device Problem Burst Container or Vessel (1074)

Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use one sprinter legend otw ptca balloon catheter to treat a lesion in the lad.It was reported that a balloon rupture occurred.

Manufacturer Narrative

The target lesion was moderately calcified.The balloon was inspected and negative prep was performed prior to use with no issue noted.There was some degree of resistance in advancing the balloon catheter across the lesion.Excessive force was not used.The balloon rupture occurred during first inflation at nominal pressure.The device was not moved or repositioned in the lesion prior to the rupture.Blood was noted in the indeflator when device when placed on negative pressure.Dissection of the lad was noted after the inflation.Loss of flow was noted and the decision was made to place an iabp and send the patient to the or for bypass, given that the lesion could not be dilated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND OTW
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8105592
• MDR Text Key: 128403743
• Report Number: 9612164-2018-03366
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169854949
• UDI-Public: 00643169854949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103095
• 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,Followup,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Catalogue Number: SPL12510WL
• Device Lot Number: 215588453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2019
• Date Device Manufactured: 06/04/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 56