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

Catalog Number	CP-08903
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after use, during removing, the device broke and the distal part remained in the vein.The doctor tried to remove it by surgery by inguinal level, without success.It has been removed completely by percutaneous way.This did not cause clinical complication to the patient and maintained in stable hemodynamic condition".The doctor was able to retrieve the device in its entirety.There was no report of patient death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "sheath body separation" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that "after use, during removing, the device broke and the distal part remained in the vein.The doctor tried to remove it by surgery by inguinal level, without success.It has been removed completely by percutaneous way.This did not cause clinical complication to the patient and maintained in stable hemodynamic condition".The doctor was able to retrieve the device in its entirety.There was no report of patient death.
Event or Problem Description
It was reported that "after use, during removing, the device broke and the distal part remained in the vein.The doctor tried to remove it by surgery by inguinal level, without success.It has been removed completely by percutaneous way.This did not cause clinical complication to the patient and maintained in stable hemodynamic condition".The doctor was able to retrieve the device in its entirety.There was no report of patient death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "sheath body separation" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint has been reopened to investigate the device that was returned to teleflex.The reported complaint of sheath body separation is confirmed.The sheath was returned with a sheath body separation consistent with a force tear.The root cause of this complaint is undetermined, but a potential cause is forceful catheter insertion/removal through the sheath.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.This is an isolated incident.There are no similar complaints.No further action required at this time.

• Brand Name: CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7808775
• Report Number: 3010532612-2018-00268
• Device Sequence Number: 19132145
• Product Code: DQY
• UDI-Device Identifier: 00801902001610
• UDI-Public: 00801902001610
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CP-08903
• Device Lot Number: 14F15F0421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/27/2018; 10/22/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1