MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC 1-LUMEN: 4FR X 55CM W/ 80CM SS S; CATHETER INTRAVASCULAR THERAPE

Catalog Number PR-35541-HPSM

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Picc placed without incident in january and was later removed.The patient complained of feeling something in the arm.An ultrasound was performed and part of the peel-away sheath was found retained in the veins of the arm.The sheath was successfully removed from the patient.It was reported the patient did have some arm pain two days after removal.There was concern for a dvt, but ultrasound was negative.There was no further follow-up with the patient and it was assumed the patient had made a complete recovery.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer provided two photos for evaluation.The photos displayed a portion of a peel-away sheath body.The sheath body appeared mainly intact with one major kink/bend.A full visual inspection could not be performed as the sample was not returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit instructs the user, "withdraw peel away sheath over catheter until free from venipuncture site.Grasp tabs of peel-away sheath and pull apart , away from catheter, until sheath splits down entire length." the customer report of a separated sheath body was confirmed by visual inspection of the customer supplied photos.However, complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: corrected data: section d.1.-brand name corrected to arrow pi picc 1-lumen: 4fr x 55cm w/ 80cm ss s.Section d.4.-catalog# corrected to pr-35541-hpsm.

Event Description

Picc placed without incident in january and was later removed.The patient complained of feeling something in the arm.An ultrasound was performed and part of the peel-away sheath was found retained in the veins of the arm.The sheath was successfully removed from the patient.It was reported the patient did have some arm pain two days after removal.There was concern for a dvt, but ultrasound was negative.There was no further follow-up with the patient and it was assumed the patient had made a complete recovery.

• Brand Name: ARROW PI PICC 1-LUMEN: 4FR X 55CM W/ 80CM SS S
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11668849
• MDR Text Key: 248233510
• Report Number: 9680794-2021-00152
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K073451
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: PR-35541-HPSM
• Device Lot Number: 14F20G0117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention