MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI CARAVEL MICROCATHETER 135 CM; CARDIAC CATHETER

Catalog Number CRV135-19P US2

Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

Caravel catheter tip broke off and migrated to pda.Dr (b)(6) was unable to snare the tip, was planning on trapping tip with stent when it appeared inside guide.Dr was able to remove tip inside guide and take out of pt's body.Diagnosis or reason for use: cad."is the product compounded: no; is the product over-the-counter: no." event abated after the use stopped or dose reduced: no; event reappeared after reintroduction: no.

• Brand Name: ASAHI CARAVEL MICROCATHETER 135 CM
• Type of Device: CARDIAC CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; TH
• MDR Report Key: 7689287
• MDR Text Key: 114217872
• Report Number: MW5078387
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 24547327108779
• UDI-Public: 24547327108779
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2018

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: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CRV135-19P US2
• Device Lot Number: 180319K051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 110