MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number AI-07155-KS

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the introducer wire in the pacer kit was attempted to advance over the needle with no success.It seems that the wire was getting stuck at the hub of the needle.Another kit with a different lot was used successfully.There was no patient complications.There was no reported patient death or serious injury.

Manufacturer Narrative

Qn#: (b)(4).See mdr #3010532612-2018-00031 and tc #: (b)(4) for related complaint.Teleflex received the device for investigation.The reported complaint of dilator blocked is not confirmed.No damage or abnormalities was noted on the returned dilator and sheath.The guidewire advanced freely through the dilator.Although, the root cause of the complaint is undetermined the returned samples passed visual and functional test specifications.No further action required.

Event Description

It was reported that the introducer wire in the pacer kit was attempted to advance over the needle with no success.It seems that the wire was getting stuck at the hub of the needle.Another kit with a different lot was used successfully.There was no patient complications.There was no reported patient death or serious injury.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7314008
• MDR Text Key: 101610113
• Report Number: 3010532612-2018-00030
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

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: 11/30/2018
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 23F17K0014
• Other Device ID Number: 00801902004536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1