MAUDE Adverse Event Report: CORDIS DE MEXICO AVIATOR PLUS PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 4246030W

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 01/20/2014

Event Type  Injury  

Event Description

During use of an aviator balloon, it was reported that the physician could not advance or retrieve the device thru the shaft and it was kinked and had coiled up.The patient had to go into surgery to get it removed.Patient is doing fine.Please note that multiple attempts to gather additional patient and procedural information have been made and have been unsuccessful.

Manufacturer Narrative

During use of an aviator balloon it was reported that the physician could not advance or retrieve the device through the shaft and it was kinked and had coiled up.The patient had to go into surgery to get it removed.The patient is reported as doing fine.Please note that multiple attempts to gather additional patient and procedural information have been made and have been unsuccessful.The device was not returned for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.With the limited information available, and no product return, the reported pta system ¿impeded¿, ¿kinked/bent in patient¿ and ¿withdrawal difficulty ¿ unable to¿ could not be confirmed and no determination regarding potential contributing factors could be made.Based on the available information and the device history record review, there is no indication that the events are related to the device manufacturing process.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion updated to include additional information: during use of an aviator balloon it was reported that the physician could not advance or retrieve the device as it kinked and coiled up.The balloon shaft remained in the patient.The patient was taken to surgery for removal.The device was removed through two separate incisions.The patient is doing fine.Vessel characteristics are unknown.The intended procedure was ¿s&i abdominal runoff/bilateral iliofemoral-lower extremity.¿ the right brachial artery was accessed.At one point, a 6x20 aviator plus was used to work on the superficial femoral stenosis.There was difficulty passing the balloon distally and a loop was visualized in the shoulder subclavian area.Attempts were made to withdraw the balloon to reduce the loop, but were unsuccessful.The procedure was aborted.Attempts were made to pull the catheter, but significant resistance was felt.The sheath was removed in an attempt to try to take the whole system out without success.The patient was taken to the or for removal of the retained balloon.Findings at surgery reflect that the balloon wire was looped in the intima and the lumen of the brachial artery, above and below the antecubital space.The device was removed through two separate incisions.There was no further complications post procedure.The physician involved in the case felt that the incident was due to an anatomical issue a not a product failure on behalf of the aviator balloon.The device was not returned for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Without return of the device the reported ¿kinked/bent in patient¿, ¿withdrawal difficulty ¿ unable to¿ and body/shaft separated in patient¿ could not be confirmed and the exact cause could not be determined.While vessel characteristics were not made available, the physician involved in the case expressed that the difficulty experienced may have been due to the patient¿s anatomy.Based on the available information and the device history record review, there is no indication that the events are related to the device manufacturing process.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

Addendum: additional information received indicated that during cardiac catheterization the balloon shaft remained in the patient, which required transferring the patient to the or for surgical removal.The right brachial artery was accessed.At one point, a 6x20 aviator plus was used to work on the superficial femoral stenosis.There was difficulty passing the balloon distally and a loop was visualized in the shoulder subclavian area.Attempts were made to withdraw the balloon to reduce the loop, but were unsuccessful.The procedure was aborted.Attempts were made to pull the catheter, but significant resistance was felt.The sheath was removed in an attempt to try to take the whole system out without success.The patient was taken to the or for removal of the retained balloon.Findings at surgery reflect that the balloon wire was looped in the intima and the lumen of the brachial artery, above and below the antecubital space.The device was removed through two separate incisions.There was no further complications post procedure.The intended procedure was s&i abdominal runoff/bilateral iliofemoral-lower extremity.The physician involved in the case feels that the incident was due to an anatomical issue a not a product failure on behalf of the aviator balloon.Please note that a voluntary med watch was submitted by the hospital ((b)(4)).Additional information will be submitted within days of receipt.

• Brand Name: AVIATOR PLUS PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3623000
• MDR Text Key: 4177616
• Report Number: 9616099-2014-00095
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K071189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 4246030W
• Device Lot Number: 15845144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 02/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/25/2014; 05/06/2014; 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention