MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET:; CATHETER, PERCUTANEOUS

Catalog Number CL-07845

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the preliminary investigation of the returned device, the event reported occurred during use.A follow up report will be submitted upon completion of the device investigation.

Event Description

Customer complaint alleges "md was performing the procedure according to ifu.The head of the dilator was torn.So the dilator didn't enter anymore.Since then, md had to use new product.The procedure has been completed without any abnormality." alleged issue was reported as detected prior to use on the patient.The device was replaced with a new set.Customer reported no patient complication or delay in therapy.

Manufacturer Narrative

Qn#: (b)(4).The customer returned the sheath/dilator assembly and lid stock for a cl-07845 kit for evaluation.The distal tip of the dilator was deformed, showing indications of stressing and biological material.No issues were identified with the sheath.Dilator body measures 21 1/16" in length, within the range of 20 7/8" - 21 3/8" specified by the product drawing.The inner diameter of the dilator tip could not be measured due to the deformation.The dilator was able to be inserted into the sheath without issue.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this kit states to thread the tapered tip of the sheath/dilator assembly over the spring-wire guide while grasping near the skin and advancing the assembly with a twisting motion.The customer reported issue of the dilator becoming damaged in use was confirmed during the complaint investigation.Visual inspection was performed and the distal end of the dilator was deformed, showing indications that it had been excessively stressed.Based on the information and sample provided, it was determined that operational context caused or contributed to this complaint.

Event Description

Customer complaint alleges "md was performing the procedure according to ifu.The head of the dilator was torn.So the dilator didn't enter anymore.Since then, md had to use new product.The procedure has been completed without any abnormality." alleged issue was reported as detected prior to use on the patient.The device was replaced with a new set.Customer reported no patient complication or delay in therapy.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7647748
• MDR Text Key: 112801374
• Report Number: 9680794-2018-00151
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CL-07845
• Device Lot Number: 14F17D0362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1