MAUDE Adverse Event Report: ARROW INTL., INC. UNKNOWN; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number CARDIAC UNK

Device Problem Fluid/Blood Leak (1250)

Patient Problems Aortic Valve Stenosis (1717); Fever (1858); Hypoxia (1918); Heart Failure (2206); Cardiogenic Shock (2262)

Event Date 09/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an event occurred approximately six months ago with an intra-aortic balloon (iab) product.According to the clinical nurse educator (cne) at the facility she does not know any details or know who dropped the red bio-hazard bag off in her office.The sales representative visited the cne on 07/28/2014 and was told "there is no information available and there will be no information available." additional information received on 08/04/2014 stated that while in cardiac intensive care unit the iab was inserted through a sheath in the patient's (pt) right femoral artery.Four and a half days later at 0435 the intra-aortic balloon pump (iabp) was alarming for high pressure and with possible etiologies of kinking in tubing, balloon too large or balloon wrapping on itself.The rn was at bedside to assess possible and attempt to resolve high pressure alarm.The md was notified and chest x-ray ordered.There were multiple rn's and md at bedside to assess possibles and solution.Chest x-ray completed without change in placement.The iab was deflated to 37cc with appropriate waveform returning.At this time blood was noted in the tubing.The iabp was stopped and disconnected from the patient.At 0500 the fellow and another md were notified.At 0515 heparin gtt stopped and stat ptt sent.At 0600, with the md's at the bedside, medical therapy was increased: nitroprusside drip was started and mechanical ventilation settings needed to be adjusted (increased fi02 and peep), protamine was given to reverse anticoagulation before removing iabp catheter.Initial 1mg dose of protamine given.Patient tolerated dose and thus received 25mg over 10 minute.At 0630 the iabp was removed by th emd and hemostasis achieved at 0710.The iab was placed in biohazard bag to be sent to manufacturer.There was not another iab inserted.There was a delay / interruption in iabp therapy.The delay/ interruption did cause harm to the patient.The patient complications were noted as "worsening hypoxia." there was no reported patient death however medical/surgical intervention was required.The patient outcome is noted as "patient survived.".

• Brand Name: UNKNOWN
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5515918
• MDR Text Key: 40937987
• Report Number: 1219856-2014-00151
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CARDIAC UNK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 80 YR
• Patient Weight: 88