MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532598B

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Gtin # (b)(4).A review of the manufacturing documentation associated with this lot 17644341 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the gold markers on catheter mb 5f pig 110 cm 6sh came loose along length of catheter during procedure while inside the patient.Operator was concerned with this as it posed a risk of dislodging inside the patient's body.There was no patient injury reported and product will not be returned for analysis.Additional information has been requested.

Manufacturer Narrative

We evaluated the event and we do not consider this event reportable.Should we receive any additional information that changes our reporting decision we will file a report.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7196140
• MDR Text Key: 97789447
• Report Number: 9616099-2018-01784
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 532598B
• Device Lot Number: 17644341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening