MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 30CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-04830-U

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250)

Patient Problems Ischemia (1942); Thrombus (2101); Vascular System (Circulation), Impaired (2572)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blood was in the helium circuit of the balloon.It was impossible to remove the balloon which was locked inside the left common femoral artery.The clinical consequence was ischemia of the lower left limb.Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream.The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.

Manufacturer Narrative

(b)(4).Additional information received the iab therapy was in use for 24 hours prior the nurse noticing the blood.The pump was stopped and blood did not enter it.Evaluation: teleflex received the device for analysis.A manual pump was attached to the iab upon receipt.The short driveline tubing was retro fitted to connect the manual pump to the iab with a standardized connector.The connector that allows the driveline tubing to connect to the iab short driveline tubing was not returned with the device.The one-way valve was not returned for evaluation.Hard blood clots were noted within the bladder membrane upon return.The bladder appeared torn approximately 13.0cm from the distal tip of the catheter.The bladder thickness was measured and was within specification.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint and determined that the occurrence rate is within acceptable risk limits.See other remarks section.Other remarks: conclusion: the reported complaint of blood in the helium pathway is confirmed based on visual inspection of the device.Three cuts consistent with contact from a sharp object were found on the bladder membrane allowing blood to enter the helium pathway.No abrasions were noted.The root cause of the damage is undetermined.

Event Description

It was reported that blood was in the helium circuit of the balloon.It was impossible to remove the balloon which was locked inside the left common femoral artery.The clinical consequence was ischemia of the lower left limb.Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream.The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.

• Brand Name: NARROWFLEX IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6109222
• MDR Text Key: 60110504
• Report Number: 1219856-2016-00263
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: IAB-04830-U
• Device Lot Number: 18F16D0024
• Other Device ID Number: 00801902002631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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
• Patient Outcome(s): Other; Required Intervention