MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS

Catalog Number LA6AL10

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: the balloon catheters used in the case were not returned for analysis with the launchers. As received the catheter appears undamaged. The catheter was flushed with water into a strainer. No debris came out. An. 035¿ wire passed through the lumen without resistance. The inner diameter meets specification at. 071¿. The presence of purple staining after dye tests confirms the presence of lumen lubricant. Dissection revealed coagulated blood and debris measuring less than 1 mm in size in the catheter lumen mid shaft and distal end of the catheter. The debris was sent for testing. Ftir results show the unknown materials are composed of polyurethane. The guide catheter is composed of pebax and vestamide (inner and outer jacket of catheter, respectively) and are chemically different. If information is provided in the future, a supplemental report will be issued.

Event Description

Two launcher guide catheters, one la6al10 and one la6sal10; were intended to be used to treat moderately tortuous, moderately calcified in the rca and lad, cass # 2 and 12. There was no damage noted to the device packaging. The devices were removed from the packaging with no issues. The devices were inspected with no issues. The devices were prepped per ifu with no issues. No issues were noted during maneuvering and engaging the launchers to the lesion. Resistance was encountered when advancing the balloon catheters and stents (all non-medtronic) in the launchers at straight section proximal to the secondary curve. Excessive force was not used during delivery. No patient injury is reported. The procedure was completed by replacing the launchers with non-medtronic devices. The physician felt as if the device tip hit something inside the launcher, and resistance persisted afterwards.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8390196
• MDR Text Key: 137838305
• Report Number: 1220452-2019-00020
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/09/2020
• Device Catalogue Number: LA6AL10
• Device Lot Number: 0008942982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial