MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

Patient Problems Angina (1710); Renal Failure (2041)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using a teflon sheath.The patient was moved to the intensive care unit.On (b)(6) 2015 at 9:50am the ce found blood in the gas driveline tubing.As a result, at 12:00pm the iab was removed and another iab was inserted via the same insertion site.A second intra-aortic balloon pump (iabp) was used because blood reached the pump (s/n (b)(4)).There was no reported patient death, injury or complications.A 15 minute delay/interruption in iabp therapy was noted.Medical/surgical intervention was not required.The patient outcome is listed as fine.

Manufacturer Narrative

(b)(4).Additional information received stated that the iab was removed with the sheath as one unit.Blood was confirmed on the balloon and in the gas driveline tubing.Device evaluation: returned for evaluation was a 30cc 7.5fr ultraflex iab.The distal end of the teflon sheath was approximately 7.6cm from the iab distal tip.Some damage was noted to the sheath tip.The sheath sidearm was cut off close to the sheath hub.A 40cc inflation driveline tubing was included with the sample.Some dried blood/decon was noted on the interior of the 40cc inflation driveline tubing.Blood was observed on the exterior of the cathgard and bladder.Blood/debris was observed within the one-way valve.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend was noted at approximately 67.8cm from the iab distal tip.The bladder thickness was measured at various locations and was within specification.The one-way valve was tested and failed.A vacuum was pulled on the iab and it immediately lost pressure.This was repeated five separate times with similar results.It was noted that some debris was observed within the one-way valve.See other remarks section for continuation.Other remarks: the one-way valve was properly cleaned and tested again; the one-way valve passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, abrasions were observed at approximately 10.8cm from the iab distal tip.A full thickness abrasion to the bladder was confirmed and the appearance was consistent with repeated contact with calcified plaque on the aortic wall.A lab-inventory 0.025 inch spring wire guide (swg) was front loaded through the iab luer end.Resistance was noted at approximately 9.5cm and 72.3cm from the iab luer then exited through the iab through distal tip while excreting blood through the distal tip before exiting.Blood exited with the swg.The swg was back loaded through iab distal tip.Resistance was noted at approximately 5.3cm and 68.1cm from the iab distal tip.The swg was able to advance through the central lumen.Blood exited with the swg.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A device history record review was conducted for the lot number/serial number with one relevant finding.The component was manufactured prior to the field correction action recall for sheath hub separation (capa (b)(4)).The product was not found with this issue.Conclusion: the reported complaint of blood in helium pathway is confirmed.The bladder has a full thickness abrasion which allowed blood to enter the iab.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.

Event Description

It was reported that while in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using a teflon sheath.The patient was moved to the intensive care unit.On (b)(6) 2015 at 9:50am the ce found blood in the gas driveline tubing.As a result, at 12:00pm the iab was removed and another iab was inserted via the same insertion site.A second intra-aortic balloon pump (iabp) was used because blood reached the pump ((b)(4)).There was no reported patient death, injury or complications.A 15 minute delay/interruption in iabp therapy was noted.Medical/surgical intervention was not required.The patient outcome is listed as fine.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5480257
• MDR Text Key: 39672838
• Report Number: 1219856-2016-00057
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000729
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F15B0006
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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 Age: 83 YR
• Patient Weight: 49