MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05830-LWS

Device Problem Material Rupture (1546)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hotline call.The rn from the (ccu) cardiac care unit has a 5'0" in height patient that was on (iabp) intra-aortic balloon pump therapy.The rn stated she noticed 1-2 specks of dark brown material in helium tubing and it increased over the last half an hour.The patient has a (ci) cardiac index of 1.2 but putting out 100-200 ml.Urine.The pump (s/n (b)(4)) did have possible helium loss alarms, but resumed pumping.The (css) clinical support specialist instructed the rn to stop pumping, clamp the tubing, and disconnect from the pump and call someone to remove the iab as soon as possible because there is a hole in the iab.The rn put the css on hold and came back on and said the surgeon was there and he did not want to stop pumping.The css asked to speak to the surgeon.The surgeon told the css, "we cannot just stop pumping." the css explained that the iab had a hole in it and it needed to come out asap.The surgeon reiterated that he did not want to stop pumping.The css stated the risk of helium in the vascular system and the blood in the catheter can clot and the iab may have difficulty being removed.The surgeon agreed and told the rn to stop pumping.The css spoke to the rn again, and told her to please save the iab and make sure the pump is sent to biomed to be checked for blood contamination.The rn was not sure if they would insert another iab.An additional call placed @ 0610 cdt: the css called the rn back to see how the removal went and how the patient was.The rn stated the iab was removed without difficulty and it was very bloody, but they had it in a bag for return.The rn stated the patient was hemodynamically the same, and her drugs were at the same dosages with the addition of milrinone @ 0.25 mcg.The point in the procedure when the difficulty was met was ~ 1 hour after insertion.Outcome of patient: patient stable on support drugs.

Manufacturer Narrative

(b)(4) no product was returned for evaluation.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.Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call.The rn from the (ccu) cardiac care unit has a (b)(6) height patient that was on (iabp) intra-aortic balloon pump therapy.The rn stated she noticed 1-2 specks of dark brown material in helium tubing and it increased over the last half an hour.The patient has a (ci) cardiac index of 1.2 but putting out 100-200 ml.Urine.The pump (s/n (b)(4)) did have possible helium loss alarms, but resumed pumping.The (css) clinical support specialist instructed the rn to stop pumping, clamp the tubing, and disconnect from the pump and call someone to remove the iab as soon as possible because there is a hole in the iab.The rn put the css on hold and came back on and said the surgeon was there and he did not want to stop pumping.The css asked to speak to the surgeon.The surgeon told the css, "we cannot just stop pumping." the css explained that the iab had a hole in it and it needed to come out asap.The surgeon reiterated that he did not want to stop pumping.The css stated the risk of helium in the vascular system and the blood in the catheter can clot and the iab may have difficulty being removed.The surgeon agreed and told the rn to stop pumping.The css spoke to the rn again, and told her to please save the iab and make sure the pump is sent to biomed to be checked for blood contamination.The rn was not sure if they would insert another iab.An additional call placed @ 0610 cdt: the css called the rn back to see how the removal went and how the patient was.The rn stated the iab was removed without difficulty and it was very bloody, but they had it in a bag for return.The rn stated the patient was hemodynamically the same, and her drugs were at the same dosages with the addition of milrinone @ 0.25 mcg.The point in the procedure when the difficulty was met was ~ 1 hour after insertion.Outcome of patient: patient stable on support drugs.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 5792176
• MDR Text Key: 49501992
• Report Number: 1219856-2016-00153
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18S15H0051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• 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 Age: 66 YR
• Patient Weight: 57