MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SD3-60150

Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Rupture (2208)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

The concerned device subject to this reported event, "shiden hp", an rx-type pta balloon catheter compatible with 0. 014"guidewire, is not distributed in us, however, we intend to report this case as the event occurred on one of the similar devices for "crosperio rx" , an rx-type pta balloon catheter compatible with 0. 014" guidewire, which is distributed in us under 510(k)#k152887. Since the used was not returned to the manufacturer, we were not able to analyze it. In addition, we were not able to check dhr because the batch number was unidentified. About the balloon rupture cause of this matter, a balloon extended thing guessed it as possibility by pressure across maximum expansion pressure (rbp) from maneuver information, but was not able to identify blood vessel estrangement and concrete causation with the leak of the stent graft.

Event Description

This "shiden hp" pta balloon catheter (hereafter said "balloon catheter") was employed for a post-dilatation of the stent graft. The balloon of the pta balloon catheter ruptured at an inflating pressure of 30 atm -30sec (the rated burst pressure (rbp) of this balloon catheter;20atm). Blood vessel became estranged, and leak occurred from a stent graft. Then, the physician detained a stent graft as an emergency measure more and restored it.

• Brand Name: SHIDEN HP
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082-88 ; JA 5308288
• MDR Report Key: 8665439
• MDR Text Key: 146895595
• Report Number: 3002808904-2019-00013
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: SD3-60150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/04/2019 Patient Sequence Number: 1