MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451404V5

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

During an angioplasty, a 4f 65cm tempo universal flush (uf) with 5 side holes (sh) was inserted normally through a sheath but while flushing, the physician did not see the contrast properly.When he withdrew the catheter, he noticed that it was damaged and out of order.The damage was noted after withdrawing the catheter, it was compressed/crushed and was torn.The catheters were removed intact but in one piece (i.E.No fragments left inside the body).It happened with 2 catheters with the same lot number.The device was stored and handled as per instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty in removing the products from the packaging.There were no anomalies noted when the device was taken out of the package.There was no difficulty in removing the stylet or any of the sterile packaging components.The device was not re-sterilized.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.There were no difficulty or resistance during prep.There were no difficulty or resistance during insertion of dilator.There were no difficulty or resistance during insertion over the wire.There were no difficulty or resistance during removal of dilator.There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance felt while advancing the device.There was no excessive torqueing used during advancement/delivery of the device.There was kink/bent noted after the device was removed from the patient.There was unusual force used during the procedure.There was no patient injury reported.The procedure was completed using a 3rd tempo catheter with the same lot number.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.The devices will be returned for evaluation.Other additional procedural details were requested but were unknown.

Manufacturer Narrative

During an angioplasty, two 4f tempo catheter was inserted normally through a sheath but while flushing, the physician did not see the contrast properly.When he withdrew the catheters, he noticed that it was damaged and out of order.The damage was noted after withdrawing the catheters.The catheters were compressed/crushed and torn.The catheters were removed not intact but in one piece (i.E.No fragments left inside the body).The devices were stored, handled, and prepped as per instructions for use (ifu).There were no damages noted to the products' packaging upon inspection prior to use.There was no difficulty in removing the products from the packaging.There were no anomalies noted when the devices were taken out of the package.There was no difficulty in removing the stylet or any of the sterile packaging components.The products were not re-sterilized.There were no anomalies noted during or after the devices were prepped.There was no difficulty or resistance during prep.There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance felt while advancing the device.There was no excessive torqueing used during advancement/delivery of the device.There was a kink/bend noted after the device was removed from the patient.There was unusual force used during the procedure.There was no patient injury reported.The procedure was completed using a 3rd tempo catheter with the same lot number.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.Other additional procedural details were requested but were unknown.Two non-sterile units of tempo catheters (cath tempo 4f uf 65cm 5sh) were received for analysis.The device corresponding to this complaint was unpacked in order to proceed with the product evaluation.During the visual inspection, several kinked/bent conditions were observed on the body of the catheter located at 3.4, 3.7, 4.5, 51.9, and 61.9 cm from the distal tip.A compressed/crushed area was observed at 43cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od) and results were found within specification.A product history record (phr) review of lot 17876838 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.For the second returned catheter, the reported ¿catheter (body/shaft) ¿ cracked in patient¿ was not confirmed since no cracked areas were found during visual analysis.The reported ¿catheter (body/shaft) ¿ compressed/crushed in patient¿ was confirmed since visual analysis revealed several kinked/bent areas and one compressed/crushed area on the body of the catheter.The exact root cause of the device conditions could not be conclusively determined during the analyses.However, procedural/handling factors (unusual force, interaction with other devices) might have contributed to the observed conditions on the returned catheters.Per the instructions for use (ifu), although not intended as a mitigation, ¿exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the product analyses nor the phr review results suggest that the damages on the returned catheters could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH TEMPO 4F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9783064
• MDR Text Key: 199763337
• Report Number: 9616099-2020-03544
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032007730
• UDI-Public: 20705032007730
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17876838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHEATH.