MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CORONARY GUIDING CATHETER

Catalog Number MCZCC23

Device Problems Break (1069); Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2014

Event Type  Injury  

Event Description

The user facility reported that the distal tip of a progreat microcatheter fractured during a coiling procedure.The following information was provided by the user facility: the attending physician inserted the microcatheter through a metal guide needle to perform coiling; subsequently, the distal tip of the microcatheter was fractured; the attending physician decided to leave the detached material in the patient's body; and the initial procedure was completed successfully.

Manufacturer Narrative

Based on the user facility information, non-resorbable material was left unretrieved in the patient's body.(b)(4).Results - is based upon evaluation of user facility information and pictures of involved sample; is based upon evaluation of a retained sample.Conclusions - is based upon user facility information; is based upon evaluation of a retained sample.The involved device was not returned by the user facility.Therefore, the failure investigation consisted of a review of information provided by the user facility, photographs of the actual device, quality records and evaluation of a reserve sample.The photographs confirmed that the distal end of the catheter had been fractured and the coil on the distal segment had been stretched out.An inspection of the retained sample from the reported lot confirmed that there were no defects or anomalies.Testing of the retained sample confirmed that performance specifications were met.A review of the device history record indicated that there were no production related problems for this lot number.A review of the complaint files confirmed that this lot has not been reported previously.Test samples were used to intentionally simulate the described damage to the returned device.The microcatheter was brought into close contact with the edge of the metal needle when it was withdrawn, resulting in a fracture of the distal segment.The microcatheter's simulated damage was very similar to that shown in the user facility's photographs.Although the cause of the reported event cannot be definitively determined, there is no evidence that indicates this event was related to a defect or malfunction of the catheter.The device labeling does address the potential for such an event in the warnings / precautions section of the instructions-for-use, which states, "do not manipulate and/or withdraw the microcatheter system through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle of a metal dilator may result in abrasion of the hydrophilic coating." all currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: PROGREAT CATHETER
• Type of Device: CORONARY GUIDING CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 3748206
• MDR Text Key: 19197796
• Report Number: 9681834-2014-00083
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014,04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: MCZCC23
• Device Lot Number: 131101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2014
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: MICRO GUIDEWIRE AQUA VIII (CORDIS); HANACO US GUIDE NEEDLE
• Patient Outcome(s): Other