MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6 INF TL JL 3.5 100 CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534618T

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the catheter of a 6f 3.5 100cm infiniti judkins left (jl) diagnostic catheter was found damaged when flushing (a puncture/hole anomaly is visible on the body/shaft of the catheter).The procedure was completed using another infiniti diagnostic catheter.There was no reported patient injury.There was no visible damage to the infiniti diagnostic catheter noticed prior to opening the package.There was no difficulty removing the stylet or any of the sterile packaging components.There was no reported difficulty removing the products from the packaging.The device was stored and handled per the instructions for use (ifu).The product was not re-sterilized.Excessive force was not applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.Other additional patient/procedural details were requested but were unknown/not available.The device will be returned for evaluation.Photographs were provided and available for review.As per image review: two images were received for review.Image 1 is a picture of a person holding a catheter, likely cordis.A puncture/hole anomaly is visible on the body/shaft of the catheter.Image 2 is the packaging/label of an infiniti diagnostic catheter with lot number 17888584.The device is not in the package.The seals of the package have been opened but no obvious anomalies are noted on the packaging.

Manufacturer Narrative

As reported, the 6f 3.5 100cm infiniti judkins left (jl) diagnostic catheter was found damaged when flushing.The procedure was completed using another infiniti diagnostic catheter.There was no reported patient injury.There was no visible damage to the infiniti diagnostic catheter noticed prior to opening the package.There was no difficulty removing the stylet or any of the sterile packaging components.There was no reported difficulty removing the products from the packaging.The device was stored and handled per the instructions for use (ifu).The product was not re-sterilized.Excessive force was not applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.Other additional patient/procedural details were requested but were unknown or not available.The device was not returned for analysis, however two photographs were provided and available for review.In the first picture, an open and empty packaging pouch is observed, where the following information is read on the product label: catalogue number 534-618t, lot number 17888584, use by date 2022-01-31 among other product information.The second picture shows an extended catheter with a puncture/hole at the middle of the body.No other details of the product can be noticed on the received pictures.A product history record (phr) review of lot 17888584 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft) - puncture/cut¿ was confirmed via picture analysis.A puncture condition on the body of the catheter was observed in one of the pictures provided.However, without the return of the device, the exact root cause of this damage could not be conclusively determined solely on the pictures provided.Per the instructions for use (ifu), although not intended as a mitigation, ¿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 phr review nor the picture analysis suggest that the observed damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

As reported, the 6f 3.5 100cm infiniti judkins left (jl) diagnostic catheter was found damaged when flushing.The procedure was completed using another infiniti diagnostic catheter.There was no reported patient injury.There was no visible damage to the infiniti diagnostic catheter noticed prior to opening the package.There was no difficulty removing the stylet or any of the sterile packaging components.There was no reported difficulty removing the products from the packaging.The device was stored and handled per the instructions for use (ifu).The product was not re-sterilized.Excessive force was not applied to the device during withdrawal from package.The integrity of the sterile pouch was not compromised.Other additional patient/procedural details were requested but were unknown or not available.The device was returned for analysis and two photographs were provided and available for review.In the first picture, an open and empty packaging pouch is observed, where the following information is read on the product label: catalogue number 534-618t, lot number 17888584, use by date 2022-01-31 among other product information.The second picture shows an extended catheter with a puncture/hole at the middle of the body.No other details of the product can be noticed on the received pictures.One non-sterile unit of and infiniti diagnostic catheter (cath f6 inf tl jl 3.5 100 cm) was also received for analysis.During the visual inspection, a puncture/hole was noted in the body of the catheter.No other damages or anomalies were observed.Per microscopic analysis of the puncture/hole noted during visual inspection, it seems the body material near the rupture was torn and could be due to the interaction with a sharp object from the outside of the catheter.A product history record (phr) review of lot 17888584 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) - puncture/cut¿ was confirmed since the device was received with a puncture/hole in the body.Per microscopic analysis, the device was torn and could be due to the interaction with a sharp object from the outside of the catheter.However, the exact cause of the condition reported could not be conclusively determined during the analysis.Procedural/handling factors may have contributed to the reported event.Per the instructions for use (ifu), although not intended as a mitigation, ¿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 phr review nor the product analysis suggest that the observed damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: CATH F6 INF TL JL 3.5 100 CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10078390
• MDR Text Key: 191676041
• Report Number: 9616099-2020-03709
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032014165
• UDI-Public: 20705032014165
• Combination Product (y/n): N
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/29/2020

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 534618T
• Device Catalogue Number: 534618T
• Device Lot Number: 17888584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/01/2020; 06/22/2020; 07/17/2020
• Supplement Dates FDA Received: 06/08/2020; 07/20/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1