MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-41541-MPK1A

Device Problems Break (1069); Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: peel away sheath broke (would not separate) as nurse was breaking it apart to remove it from patient.The sheath broke apart prior to the handles falling off, so the nurse was able to remove it from the patient.The nurse said she almost had the introducer fully peeled away, but when she got to the last 3 or 4 mm, the plastic broke and part of the introducer was still around the catheter because it didn't separate at the tip.

Event Description

The customer reports: peel away sheath broke (would not separate) as nurse was breaking it apart to remove it from patient.The sheath broke apart prior to the handles falling off, so the nurse was able to remove it from the patient.The nurse said she almost had the introducer fully peeled away, but when she got to the last 3 or 4 mm, the plastic broke and part of the introducer was still around the catheter because it didn't separate at the tip.

Manufacturer Narrative

Qn#(b)(4).The customer returned a used peel away sheath for investigation.The sheath was returned completely peeled and in two halves (half a and half b).Each half had a tab still connected to it.Visual examination of the sheath body extrusion revealed that the sheath did not peel along the blue score lines evenly.The edges of the separated halves appeared rippled and uneven along the score line.The distal tip of half b was jagged and uneven.A manual tug test confirmed both sheath halves were connected securely to their hubs.A device history record review was performed and no relevant findings were identified.The customer report of the peel-away sheath incorrectly tearing was confirmed through visual inspection of the returned sheath.Visual examination of the sheath body extrusion revealed that the sheath did not peel along the blue score lines evenly.The edges of the separated halves appeared rippled and uneven.A device history record review was performed and no relevant findings were identified.Based on the condition of the returned sample, the probable root cause for this issue is manufacturing related.A non-conformance request has been initiated to further investigate this issue.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8165201
• MDR Text Key: 130469987
• Report Number: 1036844-2018-00315
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 23F18H0726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1