MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 18 GA X 2-1/2" INTRODUCER NEEDLE: ECHOGENIC; SPRING WIRE GUIDE PRODUCTS

Catalog Number AN-04318

Device Problems Material Separation (1562); Physical Resistance (2578)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: darterectomy, left femoral to popliteal artery bypass above the knee using 6mm polytetrafluoroethylene (ptfe) graft, operative arteriogram, and left iliac balloon angioplasty qn#(b)(4).No sample will be returned for evaluation.(b)(4).

Event Description

The information was provided via medwatch report.It was reported the procedure was being performed on a (b)(6) white male patient weighing (b)(6).In (b)(6) the patient underwent a left femoral endarterectomy, left femoral to popliteal artery bypass above the knee using 6mm polytetrafluoroethylene (ptfe) graft, operative arteriogram, and left iliac balloon angioplasty which was successful.The patient did have significant blood loss during the procedure requiring blood transfusions postoperatively.We observed there was some small amount of bleeding from his incision which was controlled with staples.The patient stabilized and was ambulated.Because of the blood loss, it was initially thought to make sure he did not have any retroperitoneal bleeding.A ct of the abdomen and pelvis was performed showing no evidence of bleeding, however, a wire was seen in the left common femoral artery, probably a piece from the wire used at the time of his balloon angioplasty of the iliac artery.Interventional radiology was consulted and removed the object successfully without complication on three days after the initial surgery through a right femoral puncture.Pathology described the specimen as a gray flexible thread like foreign object measuring 10.7cm in length by less than 0.1 cm in diameter.No tissue is grossly adherent to the specimen.The surgeon noted: the wire was removed, appears to be a small segment of a sheath of the glidewire that was used during the balloon angioplasty.The patient was discharged home in stable condition six days after initial surgery to be seen as an outpatient at the physician's office.The apparent cause of the occurrence is unknown.The primary surgeon believes a section of the outer coating of the glidewire was dislodged and retained in the artery.The investigation was unable to determine exactly how the section of coating was dislodged from the main wire.The primary surgeon feels it is possible the introducer needle caught a section of the coating and dislodged it from the main wire.The object was not visualized on intraoperative films due to the lower resolution of c-arm images and interference from adjacent hip implant.The intraoperative c-arm films were scrutinized retrospectively which verified the object is only faintly visible and unlikely that the surgical team would have been able to visualize the object.Due to the small size of the object dislodged from the main wire, it may not have been easily noticed as detached.Staff in the procedure did not recall visualizing any damage to the glidewire during or after the procedure.No additional information is available as the hospital information is unknown.

• Brand Name: 18 GA X 2-1/2" INTRODUCER NEEDLE: ECHOGENIC
• Type of Device: SPRING WIRE GUIDE PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6204694
• MDR Text Key: 63330263
• Report Number: 3003737899-2016-00054
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AN-04318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (B)(6) THE PATIENT UNDERWENT A LEFT FEMORAL EN
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 110